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
82297–82320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2000
UM-L25
K000222 · GEX
Union Medical Engeneering Co., Ltd.
General & Plastic Surgery · 86d
Cleared Apr 19, 2000
HYSTALOG HSG CATHETER
K000340 · HES
Rocket Medical Plc
Obstetrics & Gynecology · 76d
Cleared Apr 19, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED...
K000408 · HIS
Suretex Prophylactics , Ltd.
Obstetrics & Gynecology · 71d
Cleared Apr 19, 2000
GETTIG GUARD
K000455 · FMI
Gettig Pharmaceutical Instrument Co.
General Hospital · 68d
Cleared Apr 19, 2000
VIEW NT
K000474 · LLZ
Electromed Intl., Ltd.
Radiology · 65d
Cleared Apr 19, 2000
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
K000478 · IWB
Accuray, Inc.
Radiology · 65d
Cleared Apr 19, 2000
GE LOGIQ 700
K000516 · IYO
Ge Medical Systems, Inc.
Radiology · 63d
Cleared Apr 19, 2000
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
K000936 · GEI
Mitek Products
General & Plastic Surgery · 27d
Cleared Apr 19, 2000
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
K000961 · GEI
Aaron Medical Industries
General & Plastic Surgery · 26d
Cleared Apr 19, 2000
LIFECARD CF COMPACT RECORDER
K001025 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 20d
Cleared Apr 19, 2000
OIL FOR TISSUE CULTURE
K991380 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 364d
Cleared Apr 19, 2000
BIOCERAMIC ORBITAL IMPLANT
K992294 · HPZ
Fci Ophthalmics, Inc.
Ophthalmic · 287d
Cleared Apr 19, 2000
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
K993268 · BTT
Mallinckrodt Dar S.R.L.
Anesthesiology · 202d
Cleared Apr 18, 2000
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
K000106 · GEX
Fotona D.D.
General & Plastic Surgery · 96d
Cleared Apr 18, 2000
PM 2002 PROLINE/AEC
K000163 · EHD
Planmeca Oy
Radiology · 90d
Cleared Apr 18, 2000
CSM STRETTA SYSTEM
K000245 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 82d
Cleared Apr 18, 2000
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
K000400 · DKZ
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
K000402 · LCM
Drug Detection Devices, Ltd.
Toxicology · 71d
Cleared Apr 18, 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487 · KGN
Medtrade Products , Ltd.
General & Plastic Surgery · 64d
Cleared Apr 18, 2000
THERMOFLEX SYSTEM
K000508 · KNS
Argomed, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 18, 2000
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
K000522 · DIS
Drug Detection Devices, Ltd.
Toxicology · 62d
Cleared Apr 18, 2000
GE LOGIQ 700
K000571 · IYO
GE Medical Systems
Radiology · 56d
Cleared Apr 18, 2000
QUIK-CAP
K000865 · GXY
Neuroscan
Neurology · 32d
Cleared Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · JJW
Bio-Rad
Chemistry · 29d