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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
61033–61056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 15d
Cleared Nov 27, 2006
OX-SOX, MODEL C, D, E,
K062300 · ECX
Pattient Safety Innovations, Llp
Anesthesiology · 111d
Cleared Nov 27, 2006
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · MQC
Dentsply Intl., Inc.
Dental · 68d
Cleared Nov 27, 2006
ACCU-CHEK LINKASSIST
K063146 · KZH
Disetronic Medical Systems AG
General Hospital · 42d
Cleared Nov 27, 2006
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299 · LRG
Dade Behring, Inc.
Microbiology · 26d
Cleared Nov 22, 2006
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES
K061517 · MQX
Prime Herbs Corporation
General Hospital · 174d
Cleared Nov 22, 2006
BIOHORIZONS CERAMIC ABUTMENT
K061567 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Nov 22, 2006
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K061608 · IYN
Hitachi Medical Corp.
Radiology · 166d
Cleared Nov 22, 2006
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
K061617 · DKZ
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 166d
Cleared Nov 22, 2006
ECLIPSE TOTAL ANKLE IMPLANT
K061749 · HSN
Kinetikos Medical, Inc.
Orthopedic · 154d
Cleared Nov 22, 2006
PROPATCH SOFT TISSUE REPAIR MATRIX
K061892 · FTM
Cryolife, Inc.
General & Plastic Surgery · 142d
Cleared Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · MVN
CooperVision, Inc.
Ophthalmic · 135d
Cleared Nov 22, 2006
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
K061951 · QEZ
Possis Medical, Inc.
Cardiovascular · 135d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · DKZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 124d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1,...
K062094 · LCM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 121d
Cleared Nov 22, 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233 · MKJ
Philips Medical Systems North...
Cardiovascular · 112d
Cleared Nov 22, 2006
RADIUS SPINAL SYSTEM
K062270 · NKB
Stryker Spine
Orthopedic · 107d
Cleared Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · NBW
Bayer Healthcare, LLC
Chemistry · 104d
Cleared Nov 22, 2006
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
K062467 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 90d
Cleared Nov 22, 2006
MICRO-INFUSION SYSTEM
K062507 · QEY
Ekos Corp.
Cardiovascular · 86d
Cleared Nov 22, 2006
RETENTION FLOW OPAQUE
K062515 · EBF
Heraeus Kulzer,GmbH
Dental · 86d
Cleared Nov 22, 2006
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
K062593 · JJY
Compass Bioscience
Chemistry · 82d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE,...
K062637 · DJR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 78d
Cleared Nov 22, 2006
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K062638 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 78d