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
39553–39576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2013
THD N-ANO ANOSCOPE
K133687 · FER
Thd Spa
Gastroenterology & Urology · 9d
Cleared Dec 10, 2013
TG-BODY MI&BODY S-TRAINER
K122393 · NGX
Miga Medical Co., Ltd.
Physical Medicine · 490d
Cleared Dec 10, 2013
CPR RSQ ASSIST
K123248 · LIX
Avantech, Inc.
Cardiovascular · 419d
Cleared Dec 10, 2013
CANARY BREATHING SYSTEM
K131586 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 193d
Cleared Dec 10, 2013
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
K133039 · NPJ
Mako Surgical Corporation
Orthopedic · 75d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · PSZ
Princeton BioMeditech Corp.
Microbiology · 28d
Cleared Dec 09, 2013
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · MEA
Smiths Medical Asd, Inc.
General Hospital · 297d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K130861 · MXZ
Dako North America, Inc.
Pathology · 256d
Cleared Dec 09, 2013
SYNGO.PLAZA VB10A
K132532 · LLZ
Siemens AG Healthcare
Radiology · 119d
Cleared Dec 09, 2013
PONTO PLUS AND PONTO PLUS POWER
K132775 · LXB
Oticon Medical AB
Ear, Nose, Throat · 95d
Cleared Dec 09, 2013
EXOSHAPE DUO SOFT TISSUE FASTENER
K132783 · MBI
MedShape, Inc.
Orthopedic · 94d
Cleared CT Dec 09, 2013
VENT-OS SINUS DILATION SYSTEM
K133016 · LRC
Sinusys Corporation
Ear, Nose, Throat · 75d
Cleared Dec 09, 2013
K7 LUMBAR SPACERS
K133126 · MAX
K7, LLC
Orthopedic · 70d
Cleared Dec 09, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K133289 · HSB
Ellipse Technologies, Inc.
Orthopedic · 45d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 338d
Cleared Dec 06, 2013
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR...
K130669 · GEI
Olsen Medical
General & Plastic Surgery · 269d
Cleared Dec 06, 2013
ANESTHESIA CONDUCTION NEEDLES
K131006 · BSP
Lccs Products Limited
Anesthesiology · 239d
Cleared Dec 06, 2013
HEART SYNC
K131550 · MKJ
Heart Sync, Inc.
Cardiovascular · 191d
Cleared Dec 06, 2013
K SERIES CPAP SYSTEMS
K131702 · BZD
Curative Medical, Inc.
Anesthesiology · 178d
Cleared Dec 06, 2013
OSTEOMED NEURO RONGEUR
K131851 · HAE
Osteomed
Neurology · 168d
Cleared Dec 06, 2013
FAMILY OF COOLGLIDE AESTHETIC LASERS
K132185 · GEX
Cutera, Inc.
General & Plastic Surgery · 144d
Cleared Dec 06, 2013
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202 · LGZ
Enthermics Medical Systems, Inc.
General Hospital · 143d
Cleared Dec 06, 2013
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · DZE
Cowellmedi Co., Ltd.
Dental · 141d
Cleared Dec 06, 2013
CD HORIZON SPINAL SYSTEM
K132328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d