FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
109057–109080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1994
NON-PRESCRIPTION SUNGLASSES
K940958 · HQY
Great Future Works , Ltd.
Ophthalmic · 78d
Cleared May 18, 1994
MON-KLENZ
K941163 · FLG
Calgon Vestal Div.
General Hospital · 68d
Cleared May 18, 1994
TAP EXPRESS EJECTOR
K941164 · EHZ
Tap Express, Inc.
Dental · 68d
Cleared May 18, 1994
MODEL 2200 THORACIC SUCTION PUMP
K941525 · JCX
Product & Educational Services
General & Plastic Surgery · 49d
Cleared May 18, 1994
MODEL 2000 MILD INTERMITTENT SUCTION PUMP
K941526 · JCX
Product & Educational Services
General & Plastic Surgery · 49d
Cleared May 18, 1994
MODEL 2300 GENERAL PURPOSE SUCTION PUMP
K941527 · JCX
Product & Educational Services
General & Plastic Surgery · 49d
Cleared May 18, 1994
RETRO MIRROR
K941574 · EAX
Union Broach, Div. Moyco Industries,...
Dental · 48d
Cleared May 18, 1994
STATVAC PORTABLE SUCTION UNIT
K941578 · BTA
Laerdal California, Inc.
General & Plastic Surgery · 48d
Cleared May 18, 1994
BONE MARROW BIOPSY TRAY
K941846 · LRO
Kormed, Inc.
General & Plastic Surgery · 34d
Cleared May 17, 1994
FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE
K922711 · HIH
Optimed Technologies, Inc.
Obstetrics & Gynecology · 711d
Cleared May 17, 1994
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 670d
Cleared May 17, 1994
READER
K926248 · LRH
Alamar Biosciences Laboratory, Inc.
Microbiology · 519d
Cleared May 17, 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · HWC
Linvatec Corp.
Orthopedic · 288d
Cleared May 17, 1994
OMNI PREP GEL
K933797 · GYB
Cadwell Laboratories, Inc.
Neurology · 286d
Cleared May 17, 1994
AOR-TEX VASCULAR GRAFT
K933987 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 273d
Cleared May 17, 1994
URINARY DRAINAGE BAG
K934142 · EXR
Key Medical Services, Inc.
Gastroenterology & Urology · 265d
Cleared May 17, 1994
CYTOCARE DIODE LASER SYSTEM
K934211 · GEX
Cytocare, Inc.
General & Plastic Surgery · 260d
Cleared May 17, 1994
FIBEROPTIC ILLUMINATED INSTRUMENTS
K934269 · HJM
Visitec Co.
Ophthalmic · 259d
Cleared May 17, 1994
SUNGLASS
K934659 · HQY
South American Plastic Manufactory...
Ophthalmic · 238d
Cleared May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · JBQ
Sigma Diagnostics, Inc.
Hematology · 196d
Cleared May 17, 1994
SUNLOVERS, CHARLES JOURDAN, COURREGES SUNGLASSES
K935422 · HQY
Sunlovers Sunglasses
Ophthalmic · 189d
Cleared May 17, 1994
MOVING IMAGES(TM)
K935518 · BZQ
Epm Information Systems, Inc.
Anesthesiology · 195d
Cleared May 17, 1994
SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES
K935563 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 181d
Cleared May 17, 1994
MAMOSPAT
K935608 · IZH
E.V.S. Tool & Die Co., Inc.
Radiology · 179d