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
39433–39456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2013
OCULAR FORCE GAUGE
K132917 · HKY
Ocular Therapeutix, Inc.
Ophthalmic · 94d
Cleared Dec 20, 2013
WANDY SELF-ADHESIVE ELECTRODES
K132998 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 87d
Cleared Dec 20, 2013
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K133052 · PEK
Nuvasive, Inc.
Orthopedic · 84d
Cleared Dec 20, 2013
K-ETCHANT SYRINGE
K133078 · KLE
Kuraray Noritake Dental, Inc.
Dental · 84d
Cleared Dec 20, 2013
MESO TENDON MATRIX
K133169 · OWY
Kensey Nash Corporation Dba Dsm...
Orthopedic · 64d
Cleared Dec 20, 2013
NEOTRACT UROLIFT SYSTEM
K133281 · PEW
Neotract, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 20, 2013
LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)
K133338 · GEI
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 51d
Cleared Dec 20, 2013
ORTHOVIS PREOPERATIVE PLAN
K133367 · LLZ
Custom Orthopaedic Solutions
Radiology · 49d
Cleared Dec 20, 2013
REST ASSURED EXTRA COMFORT NITE PROTECTOR
K133423 · OBR
Ranir, LLC
Dental · 42d
Cleared Dec 20, 2013
AMPLIVUE GBS ASSAY
K133503 · NJR
Quidel Corporation
Microbiology · 36d
Cleared Dec 20, 2013
MULTI-STAGE SNARE
K133513 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 20, 2013
PATHASSIST LIGHT SEEKER
K133563 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 20, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · MCW
Boston Scientific Corp
Cardiovascular · 30d
Cleared Dec 20, 2013
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM,...
K133569 · OZT
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Dec 20, 2013
PRESSUREWIRE AERIS AGILE TIP
K133587 · DRG
St. Jude Medical Systems AB
Cardiovascular · 29d
Cleared Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
K133605 · NQX
Geneohm Sciences Canada, Inc.
Microbiology · 25d
Cleared Dec 20, 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · KRD
MicroVention, Inc.
Cardiovascular · 24d
Cleared Dec 20, 2013
GMK SHORT STEM
K133630 · JWH
Medacta International
Orthopedic · 24d
Cleared Dec 20, 2013
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
K133641 · IYO
Volcano Corporation
Radiology · 23d
Cleared Dec 20, 2013
CAPSTONE SPINAL SYSTEM
K133650 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Dec 19, 2013
COMPRESSOR NEBULIZER MODEL MCN-S600XX
K123030 · CAF
Dongguan Aidisy Machinery &...
Anesthesiology · 447d
Cleared Dec 19, 2013
SOFTVUE
K123209 · IYO
Delphinus Medical Technologies, Inc.
Radiology · 433d
Cleared Dec 19, 2013
YOUNG AGAIN
K124064 · OHS
Espansione Marketing S.P.A
General & Plastic Surgery · 353d
Cleared Dec 19, 2013
PHYSOFT AMS
K130579 · MQS
Physicians Software Systems, LLC
Gastroenterology & Urology · 289d