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
147121–147144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1985
IRIDIUM SEEDS
K850382 · IWA
Radiation Safety & Nuclear Products,...
Radiology · 195d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM NA-30
K850804 · GEX
Xanar, Inc.
General & Plastic Surgery · 169d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM MODEL NA-40
K850805 · GEX
Xanar, Inc.
General & Plastic Surgery · 169d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM NA-120
K850818 · GEX
Xanar, Inc.
General & Plastic Surgery · 168d
Cleared Aug 15, 1985
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
K852261 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 83d
Cleared Aug 15, 1985
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · KWL
Biomet, Inc.
Orthopedic · 58d
Cleared Aug 15, 1985
THERMATIC SUCTION PUMP
K852646 · BTA
H.C.H. Products, Inc.
General & Plastic Surgery · 55d
Cleared Aug 15, 1985
EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN
K853296 · BYY
Parexel Intl. Corp.
General Hospital · 9d
Cleared Aug 15, 1985
HEALTHDYNE IMPLUSE VENTILATOR
K853300 · CBK
Healthdyne, Inc.
Anesthesiology · 9d
Cleared Aug 14, 1985
FEMTEST
K844173 · HES
Bionexus, Inc.
Obstetrics & Gynecology · 293d
Cleared Aug 14, 1985
TECA TC2-64 TRANSCRANIAL DOPPLER
K850137 · DPW
Teca, Inc.
Cardiovascular · 212d
Cleared Aug 14, 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 156d
Cleared Aug 14, 1985
KITECKO ULTRASOUND STANDOFF PAD
K851982 · IYO
3M Company
Radiology · 99d
Cleared Aug 14, 1985
SONORANGER
K852549 · IYO
Ausonics Pty , Ltd.
Radiology · 58d
Cleared Aug 14, 1985
GASTRO-ENTEROSTOMY TUBE
K852707 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 49d
Cleared Aug 14, 1985
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · GZB
Cordis Corp.
Neurology · 43d
Cleared Aug 13, 1985
THE FEVER-THERM A THERM. MEASURING DEVICE
K850395 · FLL
Kma, Inc.
General Hospital · 193d
Cleared Aug 13, 1985
URINE DUO
K851225 · JTZ
Culture Kits, Inc.
Microbiology · 140d
Cleared Aug 13, 1985
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · BTR
Mallinckrodt Critical Care
Anesthesiology · 97d
Cleared Aug 13, 1985
ENDOPORT 5MM
K852031 · HET
Endotherapeutics
Obstetrics & Gynecology · 96d
Cleared Aug 13, 1985
SIERRA -OXYGEN CONCENTRATE
K852144 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 89d
Cleared Aug 13, 1985
BELIEVE DEODORANT LABIAL PADS
K852225 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 83d
Cleared Aug 13, 1985
#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT
K852314 · CAI
Sigma Medical, Inc.
Anesthesiology · 76d
Cleared Aug 13, 1985
COAGULATOR
K852492 · KQG
Med USA
Hematology · 62d