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
82801–82824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · LZA
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · JJY
Bio-Rad
Chemistry · 31d
Cleared Apr 20, 2000
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000953 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 27d
Cleared Apr 20, 2000
PICO SMOKERLYZER, MODEL EC-50
K000962 · CCJ
Bedfont Scientific, Ltd.
Chemistry · 27d
Cleared Apr 20, 2000
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
K001102 · FPA
Rd Medical Mfg., Inc.
General Hospital · 15d
Cleared Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732 · FOZ
Dumex Medical Surgical Products, Ltd.
General Hospital · 251d
Cleared Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · GKZ
Coulter Corp.
Hematology · 197d
Cleared Apr 20, 2000
FRIALIT-2 MH-2 ABUTMENT
K994174 · DZE
Friadent GmbH
Dental · 132d
Cleared Apr 19, 2000
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · MQE
Rocket Medical Plc
Obstetrics & Gynecology · 89d
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