FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91201–91224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1998
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K972747 · FRC
Propper Mfg. Co., Inc.
General Hospital · 170d
Cleared Jan 09, 1998
GALLINI ABS DEVICE
K973152 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 140d
Cleared Jan 09, 1998
ARTHROCARE SINUS ELECTROSURGERY SYSTEM
K973478 · GEI
Arthrocare Corp.
General & Plastic Surgery · 116d
Cleared Jan 09, 1998
LIFE PAK 12
K973486 · MKJ
Physio-Control Corp.
Cardiovascular · 116d
Cleared Jan 09, 1998
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION...
K973584 · ESW
Medtech Instruments
Gastroenterology & Urology · 109d
Cleared Jan 09, 1998
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K973884 · LRK
Frantz Design, Inc.
Dental · 87d
Cleared Jan 09, 1998
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP...
K973917 · FRN
Sims Deltec, Inc.
General Hospital · 86d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088 · GWM
Johnson & Johnson Professionals, Inc.
Neurology · 71d
Cleared Jan 09, 1998
KERR COMPOMER
K974105 · EBF
Sybron Dental Specialties, Inc.
Dental · 70d
Cleared Jan 09, 1998
WINGED NEEDLE HOLDER
K974327 · FHQ
Phx Technologies Corp.
Gastroenterology & Urology · 52d
Cleared Jan 09, 1998
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K974334 · LYZ
Hong Huang Tang Industrial Co., Ltd.
General Hospital · 52d
Cleared Jan 09, 1998
SUNGLASSES
K974441 · HQY
Hip Shing Fat Co., Ltd.
Ophthalmic · 45d
Cleared Jan 09, 1998
VTU-E VACUUM ERECTION SYSTEM
K974470 · LKY
Encore, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 09, 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · JPA
Boehringer Mannheim Corp.
Hematology · 32d
Cleared Jan 09, 1998
SMARTVALVE
K974589 · FPA
Icu Medical, Inc.
General Hospital · 31d
Cleared Jan 09, 1998
RANDOX INORGANIC PHOSPHOROUS
K974605 · CEO
Randox Laboratories, Ltd.
Chemistry · 30d
Cleared Jan 09, 1998
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
K974814 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 7d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 331d
Cleared Jan 08, 1998
GLYDE DAM LOLLYES
K970577 · MSC
Glyde USA, Inc.
Obstetrics & Gynecology · 328d
Cleared Jan 08, 1998
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18,...
K971442 · KPN
Humed, Inc.
Gastroenterology & Urology · 262d
Cleared Jan 08, 1998
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · EZL
Rusch Intl.
Gastroenterology & Urology · 212d
Cleared Jan 08, 1998
STELA MODEL UJ45 PACING LEADS
K972574 · DTB
Ela Medical, Inc.
Cardiovascular · 182d