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
166033–166056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1980
ASTRON AIR POWERED HIGH SPEED DE PIECE
K801684
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
SPACELINE DENTAL CHAIR-UNIT
K801685 · EIA
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
SPACELINE THREE WAY SYRINGE
K801686 · ECB
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
TORX MICRO-MOTOR LOW SPEED HANDPIECE
K801687 · EKX
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
K801688 · EGS
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
BK-7497 BULB DYNAMOMETER
K801715 · KQW
Fred Sammons, Inc.
Neurology · 11d
Cleared Aug 04, 1980
BK-7505 RADIOPAQUE GONIOMETER, 8
K801716 · KQW
Fred Sammons, Inc.
Neurology · 11d
Cleared Aug 04, 1980
BK-7511 BRASS GONIOMETER
K801717 · KQW
Fred Sammons, Inc.
Neurology · 11d
Cleared Aug 04, 1980
BK-7513 STAINLESS STEEL GONIOMETER
K801718 · KQW
Fred Sammons, Inc.
Neurology · 11d
Cleared Aug 04, 1980
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
K801719 · HRW
Fred Sammons, Inc.
Neurology · 11d
Cleared Jul 28, 1980
IPOCON 7
K800749 · ITG
Ipos Luneburg
Physical Medicine · 115d
Cleared Jul 28, 1980
MODIFIED FEEDING JEJUNOSTOMY TUBE
K800918 · KNT
Mitchell V. Kaminski, Jr., M.D.
Gastroenterology & Urology · 97d
Cleared Jul 28, 1980
URINEBAG
K801021 · KNX
Unovex of Denmark
Gastroenterology & Urology · 89d
Cleared Jul 28, 1980
ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
K801024 · HHL
The Buckeye Cellulose Corp.
Obstetrics & Gynecology · 91d
Cleared Jul 28, 1980
BLADE SEPTOSTOMY CATHETER
K801031 · DXF
Cook, Inc.
Cardiovascular · 88d
Cleared Jul 28, 1980
DILATOR, VESSEL, FOR PERC. CATHETER.
K801113 · DRE
Alva Medical, Inc.
Cardiovascular · 77d
Cleared Jul 28, 1980
OHIO FREE FLOW VACUUM REGULATOR
K801169 · KDP
Ohio Medical Products
General Hospital · 74d
Cleared Jul 28, 1980
COBE HF80, CAT. #18-580
K801178 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 28, 1980
CCD ENDOSCOPE AND ATTACHMENTS
K801247 · GCP
Welch Allyn, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 28, 1980
MAGILL CATHETER INTRO. FORCEPS
K801273 · KOA
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 60d
Cleared Jul 28, 1980
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
K801285 · CHH
Yellow Springs Instrument Co., Inc.
Chemistry · 60d
Cleared Jul 28, 1980
MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST
K801303 · KDI
Western Laboratories Corp.
Gastroenterology & Urology · 55d
Cleared Jul 28, 1980
MODEL 900K PHOTOCOAGULATOR
K801336 · HQF
Coherent Medical Division
Ophthalmic · 54d
Cleared Jul 28, 1980
EPILATOR, MODEL CP-16
K801351 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 49d