Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
40897–40920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2013
MOBIS II
K131372 · MAX
Signus Medizintechnik GmbH
Orthopedic · 50d
Cleared Jul 02, 2013
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K131401 · EOQ
Mercator Medsystems, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2013
ELLEX 2RT
K122202 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 341d
Cleared Jul 01, 2013
COOK HOLMIUM LASER FIBER
K124030 · GEX
Cook Incorporated
General & Plastic Surgery · 185d
Cleared Jul 01, 2013
HEATER-COOLER UNIT HCU 40
K130300 · DWC
Maquet Cardiopulmonary, AG
Cardiovascular · 144d
Cleared Jul 01, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K130353 · LPH
Pipeline Orthopedics
Orthopedic · 139d
Cleared Jul 01, 2013
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
K130408 · NHA
Sterngold Dental, LLC
Dental · 132d
Cleared Jul 01, 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K131705 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 20d
Cleared Jul 01, 2013
CIRONA DVT FOOT GARMENT
K131743 · JOW
Devon Medical, Inc.
Cardiovascular · 18d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917 · DQY
Cook, Inc.
Cardiovascular · 276d
Cleared Jun 28, 2013
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP...
K123275 · DHB
Phadia AB
Immunology · 252d
Cleared Jun 28, 2013
REVITIVE IX
K123354 · IPF
Actegy , Ltd.
Physical Medicine · 240d
Cleared Jun 28, 2013
NIRVANA D PERSONAL LUBRICANT (TBD)
K123427 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 233d
Cleared Jun 28, 2013
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
K123559 · NBW
Biotest Medical Corp.
Chemistry · 221d
Cleared Jun 28, 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · JDI
Smith & Nephew, Inc.
Orthopedic · 219d
Cleared Jun 28, 2013
ET SMARTFIT ABUTMENT
K123627 · NHA
Hiossen, Inc.
Dental · 217d
Cleared Jun 28, 2013
SURECALL LABOR MONITOR
K130002 · OSP
Reproductive Research Technologies, LP
Obstetrics & Gynecology · 177d
Cleared Jun 28, 2013
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
K130638 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 109d
Cleared Jun 28, 2013
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
K130724 · LLZ
Straumann USA
Radiology · 102d
Cleared Jun 28, 2013
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808 · NHA
Straumann USA
Dental · 95d
Cleared Jun 28, 2013
ZOE FLUID STATUS MONITOR
K131509 · DSB
Noninvasive Medical Technologies, Inc.
Cardiovascular · 35d
Cleared Jun 28, 2013
SUDO PATH
K131568 · GZO
Ld Technology, LLC
Neurology · 29d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619 · GNX
Quidel Corp.
Microbiology · 25d
Cleared Jun 27, 2013
LASERBRUSH
K121920 · OAP
Sunetics International Marketing...
General & Plastic Surgery · 360d