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
44761–44784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · HCG
Penumbra, Inc.
Neurology · 60d
Cleared Apr 02, 2012
CLEAR + BRILLIANT LASER SYSTEM
K120433 · ONG
Solta Medical, Inc.
General & Plastic Surgery · 49d
Cleared Apr 02, 2012
TIGER SPINE SYSTEM
K120696 · MNI
Corelink, LLC
Orthopedic · 26d
Cleared Apr 02, 2012
PATHASSIT LIGHT SEEKER
K120735 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · MID
Bio-Rad Laboratories
Immunology · 456d
Cleared Mar 30, 2012
RESPIRATORY HUMIDIFER
K110019 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 452d
Cleared Mar 30, 2012
URETRON MODEL URT
K111058 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 347d
Cleared Mar 30, 2012
ATTUNE SLEEP APNEA SYSTEM
K111549 · OZR
Apnicure, Inc.
Anesthesiology · 301d
Cleared Mar 30, 2012
DIAZYME CYSTATIN C POC TEST KIT
K111664 · NDY
Diazyme Laboratories
Chemistry · 290d
Cleared Mar 30, 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R)...
K112119 · DTK
William Cook Europe Aps
Cardiovascular · 249d
Cleared Mar 30, 2012
ULTRA BEAUTY
K112351 · NFO
Johari Digital Healthcare , Ltd.
Neurology · 227d
Cleared Mar 30, 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452 · DQO
AngioDynamics, Inc.
Cardiovascular · 218d
Cleared CT Mar 30, 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES...
K113168 · LPL
Ciba Vision Corporation
Ophthalmic · 155d
Cleared Mar 30, 2012
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
K113431 · EIH
Bettini S.P.A.
Dental · 130d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145 · BZD
Respironics, Inc.
Anesthesiology · 72d
Cleared Mar 30, 2012
ETCH-RITE SUPREME
K120213 · KLE
Pulpdent Corporation
Dental · 66d
Cleared Mar 30, 2012
GE ECHOPAC
K120221 · LLZ
Ge Healthcare
Radiology · 65d
Cleared Mar 30, 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · PDU
Avinger, Inc.
Cardiovascular · 60d
Cleared Mar 30, 2012
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA...
K120378 · EMA
Kuraray Medical, Inc.
Dental · 52d
Cleared Mar 30, 2012
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA...
K120379 · EMA
Kuraray Medical, Inc.
Dental · 52d
Cleared Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
K120563 · OUS
Microphage, Inc.
Microbiology · 35d
Cleared Mar 30, 2012
ARISURE NEUTRAL VALVE
K120799 · FPA
Yukon Medical, LLC
General Hospital · 14d
Cleared Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
K110737 · NBW
Bionime Corporation
Chemistry · 379d