FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125761–125784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1990
SURG-K SURGICAL KERATOMETER
K901553 · HLR
The Sanborn Co.
Ophthalmic · 108d
Cleared Jul 20, 1990
1 TRANSDUCER FOR COMBISON 310A
K901655 · ITX
Kretztechnik AG
Radiology · 102d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 20, 1990
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
K901874 · KFF
Kabi Diagnostica
Hematology · 85d
Cleared Jul 20, 1990
I3SYSTEM-ABD
K902007 · IYO
Innovative Imaging, Inc.
Radiology · 77d
Cleared Jul 20, 1990
SEAL RITE(TM)
K902022 · EBC
Pulpdent Corp.
Dental · 77d
Cleared Jul 19, 1990
EXEL HUBER INFUSION SET
K895770 · FPA
Exel Intl.
General Hospital · 296d
Cleared Jul 19, 1990
METRICARE ENTERAL FEEDING SYSTEM
K895923 · FPD
Metrix Co.
Gastroenterology & Urology · 281d
Cleared Jul 19, 1990
DECIDENT
K896364 · EKY
Nevin Laboratories, Inc.
Dental · 255d
Cleared Jul 19, 1990
GENESYS 6000 GAMMA COUNTER
K900087 · JJJ
Laboratory Technologies, Inc.
Toxicology · 195d
Cleared Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040 · JGS
Fresenius USA, Inc.
Chemistry · 135d
Cleared Jul 19, 1990
ISOFLO(TM) HIGH PRESSURE INJECTION LINES
K901382 · DXT
Healthdyne Cardiovascular, Inc.
Cardiovascular · 119d
Cleared Jul 19, 1990
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527 · CEK
American Research Products Co.
Chemistry · 108d
Cleared Jul 19, 1990
LIGHT, HEAD, EXAMINATION
K901706 · KZF
Burton Medical Products Corp.
General Hospital · 98d
Cleared Jul 19, 1990
TOY SUNGLASSES
K901802 · HQY
Sirco Intl. Corp.
Ophthalmic · 90d
Cleared Jul 19, 1990
FLEXIBLE EXTENDER
K902035 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 77d
Cleared Jul 19, 1990
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · FLF
3M Company
General Hospital · 77d
Cleared Jul 19, 1990
BLOOD GAS/ISE CONTROLS
K902094 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 72d
Cleared Jul 19, 1990
TRACHEAL TUBE STYLET
K902180 · BSR
Sims Surgical, Inc.
Anesthesiology · 65d
Cleared Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · JXG
Codman & Shurtleff, Inc.
Neurology · 59d
Cleared Jul 19, 1990
ANGIOGRAPHY DRAPE PACK
K902293 · LRO
Biocor Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 19, 1990
EASY BREATHER MODEL 100 ACCESSORIES
K902300 · BYT
Progressive Productions , Ltd.
Anesthesiology · 57d
Cleared Jul 19, 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
K902344 · FRC
Ati
General Hospital · 55d
Cleared Jul 19, 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 49d