FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90433–90456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1998
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT...
K974839 · MMI
First Medical, Inc.
Chemistry · 42d
Cleared Feb 04, 1998
AMYLASE
K980013 · CIJ
Ac Biochemicals, Inc.
Chemistry · 33d
Cleared Feb 04, 1998
CARESIDE ALBUMIN
K980041 · CIX
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 04, 1998
CARESIDE TOTAL PROTEIN
K980042 · CEK
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 04, 1998
T-UPTAKE MICROPLATE EIA
K980088 · KHQ
Monobind
Chemistry · 26d
Cleared Feb 03, 1998
MEDTRONIC MODEL 3998 LEAD
K971756 · GZB
Medtronic Vascular
Neurology · 267d
Cleared Feb 03, 1998
NON-REBREATHING 'T' (BE 117)
K973066 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 169d
Cleared Feb 03, 1998
RESPOSABLE BARE FIBERS
K973172 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 162d
Cleared Feb 03, 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596 · OLW
Spacelabs Medical, Inc.
Neurology · 134d
Cleared Feb 03, 1998
TYTRON C-3000
K974208 · HCS
Titronics Research & Development Co.
Neurology · 85d
Cleared Feb 03, 1998
LYSONIX IRRIGATION SYSTEM
K974233 · GBX
Lysonix, Inc.
General & Plastic Surgery · 83d
Cleared Feb 03, 1998
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
K974320 · OCL
Cryogen, Inc.
Cardiovascular · 78d
Cleared Feb 03, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL...
K974553 · GEI
3M Healthcare
General & Plastic Surgery · 78d
Cleared Feb 03, 1998
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K980196 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 02, 1998
RUMORS DYNAMIC AIR THERAPY UNIT
K972111 · IKZ
Hill-Rom, Inc.
Physical Medicine · 242d
Cleared Feb 02, 1998
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
K972119 · FAT
Medovations, Inc.
Gastroenterology & Urology · 242d
Cleared Feb 02, 1998
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · HEX
CooperSurgical, Inc.
Obstetrics & Gynecology · 203d
Cleared Feb 02, 1998
ULTRAMIST 2000
K972657 · CAF
Texas Medical Industries, Inc.
Anesthesiology · 202d
Cleared Feb 02, 1998
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
K974027 · CDP
Alfa Biotech (Uk) , Ltd.
Chemistry · 102d
Cleared Feb 02, 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · FPA
Medtronic Minimed
General Hospital · 89d
Cleared Feb 02, 1998
UTERINE MANIPULATOR/INJECTOR
K974357 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 75d
Cleared Feb 02, 1998
PERMAFLO
K974413 · EBF
Ultradent Products, Inc.
Dental · 70d
Cleared Feb 02, 1998
COMPOLUTE APLICAP
K974458 · EMA
Espe Dental-Medizin GmbH & Co.Kg.
Dental · 69d
Cleared Feb 02, 1998
DBEST ONE-STEP OVULATION TEST
K974508 · CEP
Ameritek, Inc.
Chemistry · 63d