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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127321–127344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
K896973 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
K896974 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
K896975 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · GGP
Helena Laboratories
Hematology · 40d
Cleared Feb 05, 1990
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
K900062 · IZO
U.S. Imaging, Inc.
Radiology · 33d
Cleared Feb 05, 1990
CRONEX QUANTA SR300 INTENSIFYING SCREEN
K900103 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Feb 05, 1990
TT AND HNTT BY HEMOCHRON
K900126 · GJA
International Technidyne Corp.
Hematology · 27d
Cleared Feb 05, 1990
CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
K900318 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 13d
Cleared Feb 05, 1990
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · JTN
Organon Teknika Corp.
Microbiology · 13d
Cleared Feb 05, 1990
PHARMACIA B2 MICRO EIA
K900449 · JZG
Pharmacia, Inc.
Immunology · 6d
Cleared Feb 02, 1990
ELECTRO-ACUSCOPE 85
K883911 · GZJ
Biomedical Design Instruments
Neurology · 505d
Cleared Feb 02, 1990
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · FRN
Baxter Healthcare Corp
General Hospital · 329d
Cleared Feb 02, 1990
FLEXIBLE IMMERSIBLE HYSTEROSCOPE
K892390 · HIH
Schott Fiber Optics, Inc.
Obstetrics & Gynecology · 301d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642 · JJY
Baxter Healthcare Corp
Toxicology · 296d
Cleared Feb 02, 1990
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
K894403 · JWH
Howmedica Corp.
Orthopedic · 200d
Cleared Feb 02, 1990
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
K894844 · DZE
Straumann Institute, Ltd.
Dental · 186d
Cleared Feb 02, 1990
MODEL 8100
K895629 · LNH
Medical Advances, Inc.
Radiology · 136d
Cleared Feb 02, 1990
WRIGHT VENTILOMETER VM-1
K895953 · BZG
Clement Clarke, Inc.
Anesthesiology · 114d
Cleared Feb 02, 1990
KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY
K896183 · GEX
Laserscope
General & Plastic Surgery · 100d
Cleared Feb 02, 1990
HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
K896361 · EFB
Dentalez Group
Dental · 88d
Cleared Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared Feb 02, 1990
CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
K896393 · DWC
Daily Medical, Inc.
Cardiovascular · 88d
Cleared Feb 02, 1990
MODEL: GYREX VERSION V
K896419 · LNH
Elscint, Inc.
Radiology · 86d