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
109537–109560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1994
TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
K935834 · FBN
Technology Marketing Group
Gastroenterology & Urology · 90d
Cleared Mar 07, 1994
COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC)
K935852 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 89d
Cleared Mar 07, 1994
COOK COAGULATOR PROBE
K935874 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 88d
Cleared Mar 07, 1994
BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING
K936052 · KMF
Brady Medical Products Co.
General & Plastic Surgery · 77d
Cleared Mar 07, 1994
PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
K936189 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 70d
Cleared Mar 07, 1994
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · KDC
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 68d
Cleared Mar 07, 1994
ALASTIK
K940165 · ECI
Unitek Corp.
Dental · 60d
Cleared Mar 07, 1994
VISITEC EYE PAD
K940210 · EFQ
Visitec Co.
General & Plastic Surgery · 52d
Cleared Mar 07, 1994
TUMBLE FORMS JUNIOR TRISTANDER
K940238 · INW
Camp Intl., Inc.
Physical Medicine · 47d
Cleared Mar 07, 1994
THERMAL PULP TESTER
K940260 · EAT
Union Broach, Div. Moyco Industries,...
Dental · 45d
Cleared Mar 07, 1994
EYE PAD
K940333 · HMP
Certified Safety Mfg., Inc.
General & Plastic Surgery · 41d
Cleared Mar 07, 1994
CERTI HEAT INSTANT HEAT COMPRESS
K940336 · IMD
Certified Safety Mfg., Inc.
Physical Medicine · 41d
Cleared Mar 07, 1994
AUROLITE 1C
K940361 · EJT
Argen Precious Metals, Inc.
Dental · 40d
Cleared Mar 07, 1994
AUROLITE 2B
K940434 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 07, 1994
AUROLITE 54+2
K940435 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Mar 07, 1994
GENERAL SURGERY TRAY
K940444 · LRP
Cush Medical Products
General & Plastic Surgery · 34d
Cleared Mar 04, 1994
HUBUKA HYG TOOTHBRUSH
K915576 · MMD
Hukuba Dental Corp.
Dental · 813d
Cleared Mar 04, 1994
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 617d
Cleared Mar 04, 1994
INFILTUBE
K925558 · HIF
Medsurg Industries, Inc.
Obstetrics & Gynecology · 486d
Cleared Mar 04, 1994
HANDPIECE MODELS: MS-350
K926154 · EFB
Dabi-Atlante America Corp.
Dental · 452d
Cleared Mar 04, 1994
CA AND ST
K926155 · EFB
Dabi-Atlante America Corp.
Dental · 452d
Cleared Mar 04, 1994
BODY RELAXER
K926339 · ISA
Conair Corp.
Physical Medicine · 444d
Cleared Mar 04, 1994
VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM
K931460 · LNH
General Electric Co.
Radiology · 346d
Cleared Mar 04, 1994
3M AUTOCLAVE TAPES
K932129 · JOJ
3M Company
General Hospital · 305d