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
39817–39840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2013
CONCEIVE PLUS
K131355 · PEB
Sasmar, Inc.
Obstetrics & Gynecology · 181d
Cleared Nov 07, 2013
G-ARM MULTISCAN SYSTEM
K131423 · OXO
Beijing East Whale Imaging Technology...
Radiology · 175d
Cleared Nov 07, 2013
DC 7
K131839 · GEX
Dc International, LLC
General & Plastic Surgery · 139d
Cleared Nov 07, 2013
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841 · LZA
Kimberly-Clark Corp.
General Hospital · 139d
Cleared Nov 07, 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER...
K132006 · LZA
Hartalega Sdn Bhd
General Hospital · 129d
Cleared Nov 07, 2013
Merit ASAPLP Aspiration Catheter
K132155 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 118d
Cleared Nov 07, 2013
AQUILION ONE VISION, V6.0
K132222 · JAK
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 07, 2013
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · GQG
Becton, Dickinson and Company
Microbiology · 93d
Cleared Nov 07, 2013
CLARISO PACS
K132799 · LLZ
Clariso, Inc.
Radiology · 62d
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · NBW
Unistrip Technologies, LLC
Chemistry · 744d
Cleared Nov 06, 2013
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
K130357 · BTG
Covidien, LLC
Ear, Nose, Throat · 266d
Cleared Nov 06, 2013
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
K130405 · BWC
Teleflex Medical
Anesthesiology · 260d
Cleared Nov 06, 2013
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130419 · MUH
Genoray Co., Ltd.
Radiology · 260d
Cleared Nov 06, 2013
ZTX ULTRASONIC DIATHERMY DEVICE
K130978 · PFW
Zetroz, Inc.
Physical Medicine · 211d
Cleared Nov 06, 2013
BELMONT HYPERTHERMIA PUMP
K131519 · LGZ
Belmont Instrument Corp.
General Hospital · 162d
Cleared Nov 06, 2013
LEMAITRE 8F OCCLUSION CATHETER
K132022 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 128d
Cleared Nov 06, 2013
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 127d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 460d
Cleared Nov 05, 2013
CARDIOX FLOW DETECTION SYSTEM
K122400 · DXG
Cardiox Corp.
Cardiovascular · 455d
Cleared Nov 05, 2013
DICOMPACS DX-R WITH FLAT PANEL
K131211 · MQB
Oehm Und Rehbein GmbH
Radiology · 190d
Cleared Nov 05, 2013
INFUSION SYRINGE SET
K131661 · FMF
Innovative Medical Manufacturing Co.
General Hospital · 151d
Cleared Nov 05, 2013
LEMILLS VALVULOTOME
K132047 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 126d
Cleared Nov 05, 2013
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT...
K132241 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 110d
Cleared Nov 05, 2013
EM SINUS DILATION SYSTEM
K132297 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 104d