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
106753–106776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · CGN
Beckman Coulter, Inc.
Immunology · 57d
Cleared Aug 26, 1994
MEGABEAM LATERAL FIRE
K943444 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 39d
Cleared Aug 26, 1994
MEGABEAM FIBER OPTIC DELIVERY SYSTEM
K943445 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 39d
Cleared Aug 26, 1994
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM
K943526 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 36d
Cleared Aug 26, 1994
LIVER BIOPSY KIT
K943650 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 25, 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K931029 · IKT
Chalgren Enterprises, Inc.
Neurology · 542d
Cleared Aug 25, 1994
THICK TIBIAL INSERT
K933289 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 415d
Cleared Aug 25, 1994
SHARPLAN MODEL 1080S CO2 SURGICAL LASER
K933918 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 380d
Cleared Aug 25, 1994
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K935693 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 269d
Cleared Aug 25, 1994
WINRAD TELERADIOLOGY SYSTEM
K936179 · LLZ
Line Imaging Systems
Radiology · 241d
Cleared Aug 25, 1994
HEPA AIR CLEANER
K940573 · FRF
Duracraft Corp.
General Hospital · 198d
Cleared Aug 25, 1994
MEDIAID UNIVERSAL THERMOMETER
K941673 · FLK
Polymedica Industries, Inc.
General Hospital · 142d
Cleared Aug 25, 1994
ARTHREX CIRCULAR HARVESTING SAW
K941681 · HSZ
Arthrex, Inc.
Orthopedic · 142d
Cleared Aug 25, 1994
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
K941781 · LIL
Dacomed Corp.
Gastroenterology & Urology · 136d
Cleared Aug 25, 1994
EDGE
K941996 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 122d
Cleared Aug 25, 1994
ARGYLE NEO-SERT
K942564 · FOS
Sherwood Medical Co.
General Hospital · 86d
Cleared Aug 25, 1994
LOK-ON NEEDLE DISPOSAL CONTAINER
K942624 · FMI
Medical Safety Products, Inc.
General Hospital · 85d
Cleared Aug 25, 1994
CCD ENDOCAM OFFICE 5510
K942817 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 71d
Cleared Aug 25, 1994
DEEP SUTURE
K942818 · MDM
Automated Medical Products Corp.
General & Plastic Surgery · 71d
Cleared Aug 25, 1994
PRESSURE INFUSION CUFF
K942933 · KZD
Circulatory Technology, Inc.
General Hospital · 64d
Cleared Aug 25, 1994
SHARPSAFE CAT NO. 4105, 4115 AND 4120
K942937 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 64d
Cleared Aug 25, 1994
BOSTON(R) 7 - 30(ENFLUFOCON A)
K943177 · HQD
Polymer Technology Corp.
Ophthalmic · 55d
Cleared Aug 25, 1994
STRYKER 8000 SURGERY STRETCHER
K943864 · FPO
Stryker Medical
General Hospital · 17d
Cleared Aug 25, 1994
VIDEOTOSCOPE
K943916 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 14d