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
147025–147048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1985
RIONET HEARING AID HB-71P
K852452 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · JJQ
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Aug 21, 1985
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · JDI
Howmedica Corp.
Orthopedic · 68d
Cleared Aug 21, 1985
GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY
K852662 · HAW
Neurosurgical Devices, Inc.
Neurology · 58d
Cleared Aug 21, 1985
5F ELECTRODE(LITHOTRIPTOR)
K852874 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 44d
Cleared Aug 21, 1985
OLYMPUS RIGID URETERORENOSCOPE
K852888 · FGB
Olympus Corp.
Gastroenterology & Urology · 43d
Cleared Aug 21, 1985
LEE BONE MARROW BIOPSY/ASPIRATION TRAY
K852897 · GAA
Southland Instruments, Inc.
General & Plastic Surgery · 43d
Cleared Aug 21, 1985
ENTERAL FEEDING PUMP
K852965 · FRN
Empire Industries, Inc.
General Hospital · 40d
Cleared Aug 21, 1985
TRANSFER DEVICE
K853188 · LHI
Advance Medical Designs, Inc.
General Hospital · 22d
Cleared Aug 21, 1985
EASYTOP
K853281
Hydro-Med Products, Inc.
General & Plastic Surgery · 16d
Cleared Aug 21, 1985
STAPLE REMOVER
K853286
I M, Inc.
General & Plastic Surgery · 16d
Cleared Aug 21, 1985
CAUTERY TIP CLEANING PAD
K853315
Kleen Test Products
General & Plastic Surgery · 14d
Cleared Aug 21, 1985
JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION
K853327 · FPA
Jufrey Multimed Corp.
General Hospital · 13d
Cleared Aug 21, 1985
NON-ADHERA ADHESIVE PAD 3X4
K853334 · NAD
American White Cross, Inc.
General & Plastic Surgery · 12d
Cleared Aug 20, 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · LIT
Cordis Corp.
Cardiovascular · 245d
Cleared Aug 20, 1985
HUNTLEIGH FLOWTRON AIR, AC400/2 AIR
K850910
Huntleigh Technology, Inc.
General & Plastic Surgery · 168d
Cleared Aug 20, 1985
HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300
K850945
Huntleigh Technology, Inc.
General & Plastic Surgery · 166d
Cleared Aug 20, 1985
GUIBOR MICROELECTROLYSIS UNIT 18
K851318 · KCW
Galvanic Medical Instruments, Inc.
General & Plastic Surgery · 140d
Cleared Aug 20, 1985
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K851936 · HQE
Staar Surgical Co.
Ophthalmic · 106d
Cleared Aug 20, 1985
SITE-MALIS BIPOLAR COAGULATOR MODULE
K852075 · HQO
Valley Forge Scientific Corp.
Ophthalmic · 99d
Cleared Aug 20, 1985
MEDILASER MIC MODEL MEL 440-C
K852121 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 97d
Cleared Aug 20, 1985
MEDILASER MIC MODEL MEL-445C, 15W
K852122 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 97d
Cleared Aug 20, 1985
CERAMIC ORTHODONIT APPLIANCE
K852179 · EJF
Gac Intl., Inc.
Dental · 92d
Cleared Aug 20, 1985
PHACO-BAC STOP FILTER KIT
K852208 · HQC
Staar Surgical Co.
Ophthalmic · 91d