The FDA 510(k) database tracks medical device clearances since 1976. This searchable list ranks the top 500 medical device companies by total clearances, showing which companies are most active in bringing devices to market.

Quick Stats

Metric Value
Companies Listed 500
Total Clearances 53,469
Recent (12 months) 484
Specialty Categories 16
Data Source OpenFDA API

Most Active (Last 12 Months)

Companies with the most 510(k) clearances in the past year:

Company Recent Total
Intuitive Surgical, Inc. +21 172
Olympus Medical Systems Corporation +20 80
Arthrex, Inc. +19 338
Medacta International S.A. +16 160
Shanghai United Imaging Healthcare Co., +15 78
Siemens Medical Solutions USA, Inc. +14 773
Boston Scientific Corporation +13 225
Abbott Medical +13 52
Ge Medical Systems Ultrasound and Primar +12 63
Fresenius Medical Care Renal Therapies G +11 48

Complete List

Showing 500 of 500 companies
# Company Total Recent Specialty Location Example Devices
1Abbott Laboratories882+3Clinical ChemistryAbbott Park, ILARCHITECT iGentamicin, Alinity i Rubella IgG, Alinity h-series System
2Siemens Medical Solutions USA, Inc.773+14RadiologyIssaquah, WAACUSON Maple Diagnostic Ultrasound System, Cios Select
3C.R. Bard, Inc.642+2CardiovascularCovington, GAPhasix ST Umbilical Hernia Patch
4Bd Becton Dickinson Vacutainer Systems Preanalytic6320MicrobiologySparks, MDBACTEC MGIT 960 SIR KITS
5Smith & Nephew, Inc.528+6OrthopedicMemphis, TN
6Baxter Healthcare Corp5050General HospitalBrooklyn Park Mn, MNPrisMax System Version 2, PrisMax Control Unit, ULTRAFUSE
7Medtronic Vascular4750CardiovascularSanta Rosa, CASteerant™ Super Stiff Guidewire
8Syva Co.4480Clinical ToxicologyCupertino, CA
9Biomet, Inc.4400OrthopedicWarsaw, INBiomet Kirschner Wires, StageOne™ Select Hip Cement Spacer Molds, StageOne™ Shoulder Cement Spacer Molds
10Boston Scientific Corp4320CardiovascularMaple Grove, MNLUX-Dx II, LUX-Dx II+
11Synthes (Usa)4020OrthopedicWest Chester, PASyntheCel Dura Repair
12Howmedica Corp.3730OrthopedicRutherford, NJMICRO DYNAMIC MESH, TYPE 3 FEMORAL COMPONENTS
13Zimmer, Inc.368+5OrthopedicWarsaw, INIdentity Revision Humeral Stems, Z1 Hip System, Identity Shoulder System
14Dade Behring, Inc.3430Clinical ChemistryNewark, DEPT-MULTI-CALIBRATOR
15Boehringer Mannheim Corp.3400Clinical ChemistryIndianapolis,, INELECYS IGE ASSAY, ACCU-CHEK HQ SYSTEM, ELECSYS IGE CALCHECK
16Arthrex, Inc.338+19OrthopedicNaples, FLArthrex SwiveLock Suture Anchor, Syndesmosis TightRope PRO, Arthrex SutureTak Suture Anchor
17Karl Storz Endoscopy-America, Inc.3330Gastroenterology, UrologyLos Angeles, CAKARL STORZ Holders, HOPKINS Telescopes
183M Company3310General HospitalSt. Paul, MN
19Diagnostic Products Corp.3210Clinical ChemistryLos Angeles, CAIMMULITE 2000, IMMULITE 2500 VANCOMYCIN, IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
20Instrumentation Laboratory CO3210HematologyBedford, MAHemosIL Liquid Anti-Xa, GEM Premier ChemSTAT
21Bio-Rad3190Clinical ChemistryBenicia, CABioPlex 2200 Lyme Total, BioPlex 2200 25-OH Vitamin D Kit
22Cordis Corp.3150CardiovascularFremont, CAMICRO GUIDE CATHETER ELITE, ADROIT GUIDING CATHETER
23Depuy, Inc.3030OrthopedicWarsaw, INPINNACLE CONSTRAINED ACETABULAR LINERS, LPS UPPER EXTREMITY
24Wrightmedicaltechnologyinc3020OrthopedicBloomington, MNPRO-DENSE LoVisc Bone Graft Substitute, Sterile PHALINX Hammertoe System
25Roche Diagnostic Systems, Inc.2960Clinical ToxicologySomerville, NJMODIFICATION TO ABUSCREEN ONLINE BARBITURATES
26Em Diagnostic Systems, Inc.2880Clinical ChemistryGibbstown, NJASPARTATE AMINOTRANSFERASE TEST, ALANINE AMINOTRANSFERASE TEST, EMDS ALBUMIN TEST
27Howmedica Osteonics Corp.2880OrthopedicMalwah, NJTriathlon Tritanium Asymmetric Patella, Stryker and Serf hip devices
28Beckman Instruments, Inc.2810Clinical ChemistryChaska, MN
29Helena Laboratories2800HematologyBeaumont, TXSPIFE A1AT kit, V8 SP NORMAL CONTROL, ABNORMAL CONTROL
30Dentsply Intl.2790DentalYork, PAANKYLOS C/X IMPLANT SYSTEM, IRIS - HIGH STRENGTH GLASS CERAMIC
31Fred Sammons, Inc.2780Physical MedicineBurr Ridge, ILULTRA-PAN FOR ORTHOTIC PLASTICS, ADULT PERCEPTUAL MOTOR PUZZLES, ARM SLINGS
32Beckman Coulter, Inc.266+10Clinical ChemistryChaska, MNAccess Rubella IgG, iQ200 Series, Access anti-HAV
33Roche Diagnostics Corp.2640Clinical ChemistryIndianapolos, INSUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM, ELECSYS CA 19-9 CALCHECK 5, COBAS 8000 MODULAR SERIES ANALYZER
34General Electric Co.2540RadiologyWaukesha, WIGE VEO RECONSTRUCTION OPTION, GE VIVID E9 ULTRASOUND
35E.I. Dupont DE Nemours & Co., Inc.2530Clinical ToxicologyNewark, DECRONEX RADIATION THERAPY CASSETTE
36Biomerieux, Inc.250+2MicrobiologyHazelwood, MOVITEK COMPACT PRO
37Eastman Kodak Company2380RadiologyRochester, NYKODAK ECLIPSE IMAGE PROCESSING SOFTWARE
38Medline Industries, Inc.2380General, Plastic SurgeryNortfield, ILMedline ART Skin Harvesting System
39Sigma Chemical Co.2310HematologySt. Louis, MOSIGMA GLUCOSE REAGENT, SIGMA CALCIUM REAGENT, SIGMA ELECTROLYTE REFERENCE REAGENT
40Hewlett-Packard Co.2300CardiovascularSeattle, WAHP M2376A DEVICE LINK SYSTEM
41Boston Scientific Corporation225+13CardiovascularMarborough, MAOBSIDIO™ Conformable Embolic, TheraSphere 360™ Y-90 Management Platform
42United States Surgical, A Division of Tyco Healthc2180General, Plastic SurgeryNorwalk, CTAUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER, AUTOSUTURE ABSORBABLE TACK AND APPLICATOR, AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
43Argen Precious Metals, Inc.2170DentalSan Diego, CAARGI-SATIN OR OPTI0-STAR, ARGELITE 52+
44Intermedics, Inc.2110CardiovascularAngleton, TXMODEL 430-07 ENDOCARDIAL PACING LEAD
45Aesculap, Inc.2070NeurologyCenter Valley, PAAesculap Aicon Series Container System, SQ.line KERRISON
46DePuy Orthopaedics, Inc.2060OrthopedicWarsaw, INCUPTIMIZE™ Advanced, DePuy Corail AMT Hip Prosthesis, DELTA XTEND Reverse Shoulder System
47Johnson & Johnson Professionals, Inc.2060OrthopedicRaynham, MASIPHONGUARD CSF CONTROL DEVICE, CODMAN ETHISORB DURA PATCH, CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
48Travenol Laboratories, S.A.2060Gastroenterology, UrologyRound Lake, ILBAXTER BEDSIDE SYSTEM, RESUBMITTED MICRON TRANSFUSION FILTER
49Medtronic, Inc.204+5CardiovascularMounds View, MNMC2™ Two-Stage Venous Cannula, Medtronic Stedi Extra Support Guidewire
50Steris Corporation202+6General HospitalMentor, OHCelerity™ 20 HP Biological Indicator, VERIFY STEAM Integrating Indicator
51Ethicon, Inc.201+2General, Plastic SurgeryRaritan, NJ
52Sa Scientific, Inc.1990MicrobiologySan Antonio, TXSAS FLUALERT A&B, SAS INFLUENZA A TEST, SAS INFLUENZA A & B TEST, SAS INFLUENZA B TEST
53Sherwood Medical Co.1910General HospitalBothell, WA
54Becton, Dickinson & CO1900MicrobiologySan Diego, CABECTON DICKINSON INTELLIPORT SYSTEM
55Cook, Inc.1900CardiovascularBloomington, IN
56Philips Medical Systems (Cleveland), Inc.1900RadiologyCleveland, OHPhilips CT Big Bore, Ingenuity TF, Philips iCT CT System
57Exactech, Inc.185+4OrthopedicGainesville, FLEquinoxe Shoulder System, Equinoxe Scapula Fracture System
58Osteonics Corp.1780OrthopedicMalwah, NJTriathlon Tritanium Asymmetric Patella, Stryker and Serf hip devices
59Acumedia Manufacturers, Inc.1770MicrobiologyBaltimore, MDBLOOD AGAR BASE, IMPROVED, TERGITOL 7 BROTH, SELECTIVE STREPTOCOCCUS AGAR
60Merit Medical Systems, Inc.176+4CardiovascularSouth Jordan, UTSCOUT MD Surgical Guidance System, Merit Syringe
61Cook Incorporated1750CardiovascularBloomington, INNest VT Vitrification Device, Gunther Tulip Vena Cava Filter Retrieval Set, Bakri Essential Postpartum Balloon
62Roche Diagnostics175+6Clinical ChemistryIndianapolis, INElecsys Anti-SARS-CoV-2, CoaguChek XS Plus System, Elecsys Phospho-Tau Plasma
63Shiley, Inc.1740CardiovascularIrvine, CASHILEY PERFUSION TUBING SETS, SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM, SHILEY PLEXUS VENOUS RESERVOIR, PVR1200
64Intuitive Surgical, Inc.172+21Gastroenterology, UrologySuunyvale, CAIRISeg, da Vinci SP Surgical System
65Respironics, Inc.1720AnesthesiologyMurrysville, PAAF531 Oro-Nasal SE Face Mask, Therapy Mask 3100 NC/SP, DreamWear Silicone Pillows Mask
66GE Medical Systems1690RadiologyWaukesha, WILOGIQ Totus, LOGIQ Fortis, AIR Recon DL
67Ge Healthcare168+2RadiologyChicago, ILMR Contour DL, ViewPoint 6
68Globus Medical, Inc.168+5OrthopedicAudubon, PAExcelsiusGPS™ Instruments, ANTHEM Fracture System
69Medtronic Sofamor Danek USA, Inc.168+6OrthopedicMemphis, TNCD Horizon™ Spinal System, Infinity™ OCT System
70Nihon Kohden America, Inc.1660CardiovascularFoothill Ranch, CANIHON KOHDEN QP-160AK EEG TREND PROGRAM
71Varian Medical Systems, Inc.166+5RadiologyPalo Alto, CAIDENTIFY, TrueBeam, TrueBeam STX, Edge and VitalBeam, CT/ MR Tandem and Ovoid Set
72Quinton, Inc.1640CardiovascularBothell, WAQUINTON Q-CATH
73Sigma Diagnostics, Inc.1640Clinical ChemistrySt. Louis, MOSIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
74W.L. Gore & Associates, Inc.1630CardiovascularPhoenix, AZGORE Tri-Lobe Balloon Catheter, GORE PROPATEN Vascular Graft
75Medacta International S.A.160+16OrthopedicNextAR Hip Platform, MyPAO SA guides, MSS - Humeral reverse liners extension
76Miles Laboratories, Inc.1580Clinical ChemistryBerkeley, CAMICRO-BUMINTEST REAGENT TABLETS
77Technicon Instruments Corp.1570Clinical ChemistryNew York, NYTECHNICON CHEM 1 SYST
78Medtronic Sofamor Danek1540OrthopedicMemphis, TNCD Horizon™ Spinal System, Infinity™ OCT System
79Shenzhen Mindray Bio-Medical Electronics Co., Ltd.153+10RadiologyViewMateTM Ultrasound System
80Codman & Shurtleff, Inc.1520NeurologyRaynham, MACERENOVUS Large Bore Catheter
81Siemens Healthcare Diagnostics, Inc.150+4Clinical ChemistryNew York, NYAtellica IM Total PSA II, ADVIA Centaur Anti-Thyroglobulin II, ADVIA Centaur Anti-Thyroid Peroxidase II
82American Dade1490Clinical ChemistrySanta Ana, CA
83Olympus America, Inc.1490Gastroenterology, UrologyCenter Valley, PAVIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM, ENDOEYE HD II, OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
84B. Braun Medical, Inc.1480General HospitalCenter Valley, PAIntrocan Safety 2 IV Catheter
85Toshiba America Medical Systems, In.C1460RadiologyTustin, CAVANTAGE ELAN, KALARE, APLIO ARTIDA, V3.2
86Behring Diagnostics, Inc.1450ImmunologyWestwood, MAOPUS HLH CONTROLS, N ANTISERUM TO HUMAN ALBUMIN, N ANTISERUM TO HUMAN TRANSFERRIN
87Heraeus Kulzer, Inc.1450DentalSouth Bend, INFLEXITIME FLOW, FLEXITIME BITE, HKBOND 2006
88Terumo Medical Corp.1430CardiovascularElkton, MDPINNACLE PRECISION ACCESS SYSTEM, GLIDECROSS SUPPORT CATHETER, TERUMO SUPPORT CATHETER
89Olympus Corp.1420Clinical ChemistryLake Success, NYOLYMPUS HX-20 SERIES LIGATING DEVICE, EW-10 AND EW-20, OLYMPUS PBD STENTS
90Richard Wolf Medical Instruments Corp.1420Gastroenterology, UrologyVernon Hills, ILcore nova Complete Operating Room Endoscopy, ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
91Edward Weck, Inc.1400General, Plastic SurgeryResearch Triangle Pa, NCWECK TROCAR, LM15 , CATALOG NUMBER - 523821, HEMOCLIP II
92Inova Diagnostics, Inc.1370ImmunologySan Diego, CAAptiva APS IgG Reagent, Aptiva CTD Essential Reagent, Aptiva Celiac Disease IgG Reagent
93Remel Co.1370MicrobiologyLenexa, KSBACTI-SWAB DRY, A.C.T. II, A.C.T. IV
94Datascope Corp.1360CardiovascularFairfield, NJCARDIOSAVE Intra-Aortic Balloon Pump
95Ge Medical Systems Information Technologies1360CardiovascularWauwatosa, WIMonitor B105M, Monitor B125M, Mac-Lab
96Brainlab AG135+8NeurologyViewer, Elements Viewer, Spine & Trauma Navigation Instruments
97Zeus Scientific, Inc.1350MicrobiologyRaritan, NJZeus IFA ANA HEp-2 Test System, Zeus dIFine
98Edwards Lifesciences, LLC134+4CardiovascularIrvine, CA
99J R Scientific1320HematologyWoodland, CAMEDIUM 199 W/EBSS, RPMI-1640 MEDIUM, CATALOG NO. 210-3525, EX-CELL 300TM, CATALOG NO. 210-3575
100Ivoclar North America, Inc.1310DentalAmherst, NYERIS LAYERING MATERIALS, HELIOSEAL CLEAR CHROMA, IN TEN-S
101Covidien1300General, Plastic SurgeryBoulder, COHugo™ RAS System
102Organon Teknika Corp.1300MicrobiologyDurham, NCBACT/ALERT CSR, MDA D-DIMER, BACT/ALERT MB CULTURE BOTTLE
103Becton, Dickinson and Company129+10MicrobiologyFranklin Lakes, NJBD PhaSeal™ Optima Connecting Set
104Pharmacia, Inc.1290ImmunologyWestervillle, OHALLERGAN IMMUNO CAP M4, M8, K70, UNICAP PHADIATOP
105Abco Dealers, Inc.1270General HospitalMilwaukee, WIDIGITAL THERMOMETER KITS, BLOOD COLLECTING NEEDLE AND HOLDERS
106Ortho Diagnostic Systems, Inc.1260HematologyRaritan, NJ
107Ciba Corning Diagnostics Corp.1250Clinical ChemistryIrvine, CAACS CORTISOL IMMUNOASSAY, CIBA CORNING ACS
108GC America, Inc.125+3DentalAlsip, ILG-Bond Universal, EQUIA LC ONE, G aenial Universal Injectable II
109Stryker Corp.1240OrthopedicSan Jose, CAHipCheck, Stryker CrossFlow Integrated Arthroscopy Pump
110Wako Chemicals USA, Inc.1240Clinical ChemistryMountain View, CA
111Wilson-Cook Medical, Inc.1240Gastroenterology, UrologyWinstrom-Salem, NCTeslatome Bipolar Sphincterotome, Entuit PEG, Entuit PEGJ, Instinct Plus Endoscopic Clipping Device
112Taidoc Technology Corporation1230Clinical Chemistry
113Conphar, Inc.1220General, Plastic SurgeryMchenry, ILCONPHAR SILICONE FEEDING TUBE, MAYO-HEGAR NEEDLE HOLDER, CONPHAR MAYO HEGAR NEEDLE HOLDER
114Difco Laboratories, Inc.1210MicrobiologyDetroit, MIDISPENS-O-DISC SPARFLOXACIN, DISPENS-O-DISC LEVOFLOXACIN, DISPENS-O-DISC MEROPENEM
115Ohmeda Medical1200AnesthesiologyLaurel, MDGiraffe OmniBed Carestation CS1, Giraffe Incubator Carestation CS1, GIRAFFE AND PANDA WARMERS
116Harleco1160Clinical ChemistryMchenry, ILURIC ACID STANDARD, 8MG/DL #65078, TRIGLYCERIDE CALIBRATOR, ULTRACHEM BUN-UV, 65080 & 65081
117Randox Laboratories, Ltd.1160Clinical ChemistryConcizuTrace™ ELISA, ISE Electrodes, Randox Calcium
118Voco GmbH116+2DentalMTA vpt, GrandioSO Unlimited, AlignerFlow LC
119Hologic, Inc.115+3RadiologySan Diedgo, CAPanther Fusion GI Expanded Bacterial Assay, Genius AI Detection 2.0, Aptima SARS-CoV-2 Assay
120The Binding Site, Ltd.1150ImmunologyHUMAN BETA-2 MICROGLOBULIN KIT
121Hardy Media1140MicrobiologySanta Barbara, CALOWENSTEIN-JENSEN, W/NACL, MIDDLEBROOK 7H11 AGAR, LAURYL TRYPTOSE BROTH
122Arthrocare Corp.1120General, Plastic SurgeryIrvine, CAAdjustable Fixation Device
123Nu Vasive, Incorporated1120OrthopedicSan Diego, CANuVasive CoRoent Small Interbody System, NuVasive Modulus ALIF System, Rod Registration Frame
124Buckman Co., Inc.1110OrthopedicConcord, CAFUTURELASE 3000/3002 ERBIUM LASER SYSTEM, ORTHOCHUCK
125Corning Medical & Scientific1110Clinical ChemistryOneonta, NYDISPOSABLE STERILE SYRINGE FILTERS, CORNING EASY WASH ELISA PLATES, CORNING DISPOSABLE ROLLER BOTTLES
126Data Medical Associates, Inc.1110Clinical ChemistryArlington, TXHDL-C/LDL-C CALIBRATOR, MODEL 1913-003, DMA TRIGLYCERIDES PROCEDURES, DMA GAMMA GLUTAMYLTRANSFERASE PROCEDURE
127Ethicon Endo-Surgery, Inc.1110Gastroenterology, UrologyBlue Ash, OH
128Invacare Corp.1110Physical MedicineElyria, OHTHE INVACARE FLYER, MODEL IPC 100, TWILIGHT FULL FACE MASK, EASYSTAND EVOLV
129Philips Medical Systems, Inc.1110RadiologyBothell, WAPCR ELEVA 1.2, PINNACLE3 SMARTARC
130Welch Allyn, Inc.1110CardiovascularSkaneateles Falls, NYWelch Allyn Connex 360, Welch Allyn Connex Spot Monitor, iExaminer System with Panoptic Plus
131Arrow Intl., Inc.1100CardiovascularReading, PAARROW INTERNATIONAL, INC., SURGICAL DRAPES
132Puritan Bennett Corp.1100AnesthesiologyCarlsbad, CA
133Scimed Life Systems, Inc.1090CardiovascularMaple Grove, MNSCIMED INFORMER PRESSURE WIRE SYSTEM, SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
134Hardy Diagnostics108+3MicrobiologySanta Monica, CAHardyDisk AST Cefiderocol 30µg, HardyDisk AST Gepotidacin 10µg, HardyDisk Aztreonam/Avibactam 30/20µg
135Intermedics Orthopedics1080OrthopedicAustin, TXNATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI, NATURAL-KNEE II REVISION FEMORAL SPACER LUGS, NATURAL-HIP SYSTEM COCR REVISION STEM
136Medical Analysis Systems, Inc.1070Clinical ChemistryCamarillo, CAMAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
137Microgenics Corp.1070Clinical ToxicologyFremont Blvd., CATHERMO SCIENTIFIC QMS EVEROLIMUS ASSAY, ABBOTT PHENOBARBITAL ASSAY
138Philips Medical Systems1070RadiologyLumiGuide Equipment R2.1, LumiGuide Wire, Azurion R3.1
139Telectronics, Inc.1070CardiovascularEnglewood, COIMPLANTABLE ADAPTOR 033-380, OPTIMA MPT AND SPT PACEMAKERS
140Ortho-Clinical Diagnostics, Inc.1060Clinical ChemistryRochester, NY
141Sybron Dental Specialties, Inc.1060DentalOrange, CACENTURY MODEL 105C, SONICFILL 2010
142Medrad, Inc.1050CardiovascularMinneapolis, MNJETSTREAM XC 2.4/3.4
143St Jude Medical1050CardiovascularIrvine, CAViewFlex Xtra ICE Catheter, Jot Dx Insertable Cardiac Monitor, Confirm Rx Insertable Cardiac Monitor
144Cook Urological, Inc.1040Gastroenterology, UrologySpencer, IN
145Kimberly-Clark Corp.1040Obstetrics/GynecologyRoswell, GAKIMGUARD SMART-FOLD STERILIZATION WRAP, KC 300 SURGICAL MASK
146Advanced Cardiovascular Systems, Inc.1030CardiovascularSanta Clara, CAOTW MEGALINK SDS BILIARY STENT SYSTEM, VERIPATH PERIPHERAL GUIDING CATHETER
147Resmed, Ltd.1030AnesthesiologyMoore Park Mask, Scone Mask, Astral 100/150
148Vascular Solutions, Inc.1030CardiovascularMaple Grove, MNOctane Mechanical Thrombectomy System, Bandit guidewire, VSI Micro-Introducer Kit
149Ultradent Products, Inc.1020DentalSouth Jordan, UTPeak Universal Bond, FORMA Composite, J-Temp
150Coulter Electronics, Inc.1010HematologyHialeah, FLCD8 CYTOSPHERES KIT, COULTER RETIC-C CELL CONTROL, CD4 CYTOSPHERES KIT
151Storz Instrument Co.1010
152Ge Medical Systems, LLC100+5
153Hitachi Medical Systems America, Inc.1000
154Medtronic Sofamor Danek, Inc.990
155Cynosure, Inc.980
156Olympus Medical Systems Corp.98+10
157Otisville Biotech, Inc.980
158Philips Medical Systems Nederland BV98+8
159CooperVision, Inc.970
160K2m,Inc.970
161Bayer Corp.960
162Pacesetter Systems960
163Stryker Endoscopy96+5
164Ebi, L.P.950
165Orthopedic Systems, Inc.950
166Amersham Corp.940
167Diagnostic Systems Laboratories, Inc.940
168Elscint, Inc.940
169Kelleher Corp.940
170Medos International SARL940
171United States Endoscopy Group, Inc.940
172Valleylab, Inc.940
173Biomet Manufacturing Corp930
174Isle Media and Sterile Products, Inc.930
175Linvatec Corp.930
176Oxoid U.S.A., Inc.930
177Andon Health Co, Ltd.920
178Bausch & Lomb, Inc.920
179Canon Medical Systems Corporation92+8
180Conmedcorp920
181Jedmed Instrument Co.920
182Kallestad Laboratories, Inc.920
183Mallinckrodt Critical Care920
184Meridian Diagnostics, Inc.920
185Siemens Healthcare Diagnostics920
186Stryker920
187Alphatec Spine, Inc.91+4
188Deroyal Industries, Inc.910
189Edan Instruments, Inc.91+4
190Nobel Biocare AB910
191Nuvasive, Inc.910
192Quidel Corp.910
193Shimadzu Medical Systems900
194American Edwards Laboratories890
195Fisher Scientific Co., LLC890
196Lakewood Biochemical Co., Inc.890
197Nova Biomedical Corp.890
198Adac Laboratories880
199Bisco, Inc.880
200AngioDynamics, Inc.87+2
201Covidien, LLC87+5
202Smith & Nephew Richards, Inc.870
203Gambro, Inc.860
204Institut Straumann AG86+3
205Varian Assoc., Inc.860
206Acon Laboratories, Inc.85+4
207Encore Orthopedics, Inc.850
208Hollister, Inc.850
209Microvention, Inc.850
210Biotronik, Inc.840
211Masimo Corporation84+3
212Penumbra, Inc.84+3
213Concept, Inc.830
214Asahi Intecc Co., Ltd.82+7
215Bio-Rad Laboratories, Inc.820
216Marquette Electronics, Inc.820
217Sclavo, Inc.820
218Ventrex Laboratories, Inc.820
219Conmed Corporation81+4
220Convatec, A Division of E.R. Squibb & Sons810
221Stryker Corporation810
222Xomed, Inc.810
223Encore Medical, L.P.80+7
224Life Spine, Inc.80+3
225Olympus Medical Systems Corporation80+20
226Physio-Control Corp.800
227Toshibamedical Systems Corporation800
228Treace Medical, Inc.800
229American Bioproducts Co.790
230Artiberia790
231R&D Systems, Inc.790
232Acufex Microsurgical, Inc.780
233Draeger Medical, Inc.780
234Jeneric/Pentron, Inc.780
235Pulpdent Corp.780
236Shanghai United Imaging Healthcare Co., Ltd.78+15
237Y780
238Cobe Laboratories, Inc.770
239Diagnostic Chemicals, Ltd. (Usa)770
240Nidek, Inc.770
2413M Health Care, Sarns760
242Airlife, Inc.760
243Cardiac Pacemakers, Inc.760
244Kirschner Medical Corp.760
245Sharplan Lasers, Inc.760
246Zinnanti Surgical Instruments, Inc.760
247Dutchland Laboratories, Inc.750
248Gish Biomedical, Inc.750
249Vital Signs, Inc.750
250Dow Corning Wright740
251American Monitor Corp.730
252Electone, Inc.730
253Stryker Spine730
254Unipath , Ltd.730
255American Medical Systems, Inc.720
256Baxter Diagnostics, Inc.720
257Pointe Scientific, Inc.,720
258Princeton Biomeditech Corp720
259Scientific Pharmaceuticals, Inc.720
260Biosense Webster, Inc.710
261Coloplast A/S710
262Fujifilm Medical System U.S.A., Inc.710
263Guidant Corp.710
264Mri Devices Corp.710
265Samsung Medison Co., Ltd.71+3
266Stryker Instruments71+7
267Biosearch Medical Products, Inc.700
268Chattanooga Group, Inc.700
269DiaSorin, Inc.700
270Fisher &Paykel Healthcare , Ltd.70+5
271Procter & Gamble Mfg. Co.700
272Streck Laboratories, Inc.700
273Tambrands, Inc.700
274Target Therapeutics700
275A-Dec, Inc.690
276Extracorporeal Medical Specialities, Inc.690
277Fischer Imaging Corp.690
278Honeywell, Inc.690
279Philips Medical Systems North America, Inc.690
280Richards Medical Co., Inc.690
281Sorensen Research690
282Union Carbide Corp.690
283Armkel, LLC680
284Depuy Spine, Inc.680
285Ethicon Endo-Surgery, LLC68+4
286Fukuda Denshi USA, Inc.680
287Life-Tech Intl., Inc.680
288Nichols Institute Diagnostics680
289Diamedix Corp.670
290Gibco Laboratories Life Technologies, Inc.670
291Metalor Dental USA Corp.670
292Osstem Implant Co., Ltd.670
293Unitron Industries, Inc.670
294Diagnostic Chemicals , Ltd.660
295Diagnostic Reagents, Inc.660
296Kendall Healthcare Products Co. Div.Of Tyco Health660
297Omron Healthcare, Inc.660
298Pasco Laboratories, Inc.660
299SeaSpine Orthopedics Corporation66+2
300Siemens Corp.660
301Toshiba America Mri, Inc.660
302Volu Sol Medical Industries660
303Implex Corp.650
304Integra LifeSciences Corporation65+2
305Miracle-Ear, Inc.650
306Pentax Precision Instrument Corp.650
307Ab Biodisk640
308Advanced Surgical Products, Inc.640
309American Pharmaseal Div. Ahsc640
310Esaote, S.P.A.64+3
311Nobelpharma USA, Inc.640
312Thermo Fisher Scientific64+10
313Allegiance Healthcare Corp.630
314Atrium Medical Corp.630
315Daig Corp.630
316Dentsply Sirona63+5
317Ge Medical Systems Ultrasound and Primary Care Diagnostics63+12
318Icu Medical, Inc.63+5
319Ivoclar Vivadent, Inc.630
320Lima Corporate S.P.A.63+3
321Medical Components, Inc.630
322Reagents Applications, Inc.630
323Siemens Elema AB630
324Sterilmed, Inc.630
325Teleflexmedical, Inc.630
326Emd Chemicals, Inc.620
327Gen-Probe, Inc.620
328Hybritech, Inc.620
329Kinetic Medical Products620
330National Medical Care, Medical Products Div., Inc.620
331The Perkin-Elmer Corp.620
332Advanced Technology Laboratories, Inc.610
333Hartalega Sdn Bhd610
334Mentor Corp.610
335The Kendal Co.610
336Usa Instruments, Inc.610
337Wembley Rubber Products (M) Sdn Bhd610
338Barco N.V.600
339Conformis, Inc.600
340Downs Surgical , Ltd.600
341Health & Life Co., Ltd.600
342Keeler Instruments, Inc.600
343Orthomet, Inc.600
344Sherwood Medical Industries600
345Sorin Group Italia S.R.L.60+5
346American Bentley590
347AtriCure, Inc.59+2
348Baxter Healthcare Corporation59+5
349Empi590
350Espe GmbH (Us)590
351Laserscope590
352Materialise N.V59+4
353Starkey Laboratories, Inc.590
354The Anspach Effort, Inc.590
355Applied Medical Resources580
356Datex-Ohmeda, Inc.580
357Depuy Mitek, A Johnson & Johnson Company580
358Excel Tech. , Ltd.580
359Incstar Corp.580
360Kallestad Diag, A Div. of Erbamont, Inc.580
361Maico Hearing Instruments, Inc.580
362Analytical Products, Inc.570
363Boston Scientific57+3
364Corin USA570
365Ferguson Medical570
366Flow Laboratories, Inc.570
367Fujifilm Corporation57+8
368Gull Laboratories, Inc.570
369KLS- Martin L.P.57+3
370Medical Advances, Inc.570
371Medical Diagnostic Technologies, Inc.570
372Orthofix, Inc.570
373Oticon Corp.570
374Quanta System Spa57+2
375Shofu Dental Corp.570
376American Hospital Supply Corp.560
377American Research Products Co.560
378Danek Medical, Inc.560
379Dlp, Inc.560
380E-Z-Em, Inc.560
381G.D. Searle and Co.560
382Kontron Instruments, Inc.560
383Prismatik Dentalcraft, Inc.56+5
384Trek Diagnostic Systems, Inc.560
385Trimedyne, Inc.560
386Aspen Laboratories, Inc.550
387Bentley Laboratories, Inc.550
388Graphic Controls Corp.550
389Hospal Medical Corp.550
390Immco Diagnostics, Inc.550
391J.F. Jelenko & Co., Inc.550
392Northgate Technologies, Inc.550
393Radionics, Inc.550
394Spine Wave, Inc.55+3
395Advanced Sterilization Products540
396Cooper Lasersonics, Inc.540
397Dako Corp.540
398Datex Division Instrumentarium Corp.540
399Del Mar Avionics540
400Elias U.S.A., Inc.540
401Ge Medical Systems, Inc.540
402J.T. Baker Chemical Co.540
403Microlife Intellectual Property GmbH540
404Surgikos, Inc.540
405Toshiba Medical Systems540
406Walter Lorenz Surgical, Inc.540
407Coloplast Corp.53+3
408Johnson & Johnson Medical, Inc.530
409Meadox Medicals, Div. Boston Scientific Corp.530
410The Huxley Instrument Corp.530
411Trace Scientific , Ltd.530
412Volcano Corporation530
413Abbott Medical52+13
414Anaerobe Systems520
415Hemagen Diagnostics, Inc.520
416Imm Enterprises , Ltd.520
417Jeil Medical Corporation52+6
418L & K Biomed Co., Ltd.52+3
419Lkb Instruments, Inc.520
420Micro Media Laboratories520
421Parkell, Inc.520
422Proteins Intl., Inc.520
423Smiths Medical Asd, Inc.520
424Spineology, Inc.52+2
425Hi Chem, Inc.510
426Hycor Biomedical, Inc.510
427Implant Innovations, Inc.510
428J. Morita USA, Inc.510
429Maddak, Inc.510
430Micro Therapeutics, Inc.510
431Nxstage Medical, Inc.510
432Rion Acoustic Instruments, Inc.510
433Siemens Gammasonics, Inc.510
434Widex Hearing Aid Co., Inc.510
435Bivona Medical Technologies500
436Coulter Corp.500
437Critikon Company, LLC500
438E K Ind., Inc.500
439Gilford Diagnostics500
440Immunalysis Corporation500
441Megadyne Medical Products, Inc.500
442Mortara Instrument, Inc.500
443Origin Medsystems, Inc.500
444Pioneer Surgical Technology500
445Van-Tec, Inc.500
4463M Health Care, Ltd.490
447Biomerieux Vitek, Inc.490
448Bionostics, Inc.490
449Card Guard Scientific Survival , Ltd.490
450Leeco Diagnostics, Inc.490
451Medical Devices, Inc.490
452Medipart Jerry Alexander490
453Nonin Medical, Inc.490
454Numed, Inc.490
455R & D Batteries, Inc.490
456Stryker GmbH49+3
457Tornier, Inc.49+2
458Candela Corp.480
459Canon USA, Inc.480
460Davol, Inc.48+2
461Depuyacromed480
462Draeger Medical Systems, Inc.480
463Fresenius Medical Care Renal Therapies Group, LLC48+11
464Hoffmann-La Roche, Inc.480
465Icl Scientific480
466Innovative Health, LLC480
467Kinetic Concepts, Inc.480
468Ocular Instruments, Inc.480
469Paragon 28, Inc.48+6
470Phx Technologies Corp.480
471Richard'S Medical Equip., Inc.480
472Surgical Laser Technologies, Inc.480
473Telex Communications, Inc.480
474Carestream Health, Inc.470
475Centrix, Inc.470
476Collagen Matrix, Inc.470
477Devon Industries, Inc.470
478Granite Diagnostics, Inc.470
479Hazleton Research Products, Inc.470
480International Technidyne Corp.470
481Lin-Zhi International, , Inc.470
482Medex, Inc.470
483Medica Corp.470
484Medtronic Minimed470
485Onyx Medical Corp.470
486Oscor, Inc.470
487Roche Molecular Systems, Inc.47+9
488Teco Diagnostics470
489Aaron Medical Industries460
490Alcon Laboratories460
491Bayer Healthcare, LLC460
492Bio-Rad Laboratories460
493Biosite Incorporated460
494Biotrol, USA, Inc.460
495Cadwell Laboratories, Inc.460
496Cepheid460
497Deringer-Ney, Inc.460
498Mill-Rose Laboratory460
499Parke-Davis Co.460
500Philips Medizin Systeme Boeblingen GmbH460

About This Data

This list is generated from the OpenFDA Device 510(k) API, which provides public access to FDA clearance data from 1976 to present.

Columns explained:

  • Total: All-time 510(k) clearances for this company
  • Recent: Clearances in the past 12 months (shows current activity)
  • Specialty: Primary device category (advisory committee)
  • Location: Company headquarters from most recent submission
  • Example Devices: Sample of cleared devices from this company

Note: Some companies appear under multiple names due to acquisitions or subsidiaries (e.g., "Medtronic Vascular" and "Medtronic, Inc." are listed separately).

Data source: OpenFDA API. Last updated: January 22, 2026

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