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
39769–39792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2013
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K132741 · OMP
Kci USA, Inc.
General & Plastic Surgery · 73d
Cleared Nov 15, 2013
MAGNETOM AERA
K132951 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Nov 15, 2013
SHARPSOLOGY 2
K133031 · MMK
Industrial Water Solutions, Inc.
General Hospital · 50d
Cleared Nov 15, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · GQG
Becton, Dickinson & CO
Microbiology · 29d
Cleared Nov 15, 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION...
K133142 · IYO
Volcano Corporation
Radiology · 29d
Cleared Nov 14, 2013
IQ IMPLANTS
K130829 · DZE
Iq Implants , Ltd.
Dental · 233d
Cleared Nov 14, 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · DXN
Robert Bosch Healthcare Systems, Inc.
Cardiovascular · 216d
Cleared Nov 14, 2013
ANKER DENTAL IMPLANT SYSTEM
K131165 · DZE
Alliance Global
Dental · 204d
Cleared Nov 14, 2013
DIGITAL ELECTROCARDIOGRAPHS
K131262 · DPS
Sonoscape Company Limited
Cardiovascular · 195d
Cleared Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
K131284 · NAK
Wallac OY
Chemistry · 192d
Cleared Nov 14, 2013
MERIDIAN
K131753 · EBF
Ab Ardent
Dental · 153d
Cleared CT Nov 14, 2013
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 150d
Cleared Nov 14, 2013
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
K132527 · IYN
Sonoscape Company Limited
Radiology · 94d
Cleared Nov 14, 2013
DOSIMETRY CHECK VERSION 4 RELEASE 1
K132605 · IYE
Math Resolutions, LLC
Radiology · 86d
Cleared Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · KRD
Boston Scientific Corp
Cardiovascular · 27d
Cleared Nov 13, 2013
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
K122252 · NVP
Medical Developments International
Anesthesiology · 474d
Cleared Nov 13, 2013
KULAVAC
K122490 · OMP
CG Bio Co., Ltd.
General & Plastic Surgery · 455d
Cleared Nov 13, 2013
IDYS(TM) C
K130853 · ODP
Clariance
Orthopedic · 230d
Cleared Nov 13, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128 · DIO
Omega Laboratories, Inc.
Toxicology · 204d
Cleared Nov 13, 2013
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA...
K131904 · FIP
Ameriwater
Gastroenterology & Urology · 141d
Cleared Nov 13, 2013
U&U STERILE HYPODERMIC NEEDLE
K132552 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 91d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138 · PSZ
Becton, Dickinson & CO
Microbiology · 27d
Cleared Nov 12, 2013
I RUNE (I-200L)
K122410 · NUH
Medirune Co, Ltd.
Neurology · 461d