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
39913–39936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2013
RAUMEDIC-PTO-MONITORING-SYSTEM
K130529 · GWM
Raumedic AG
Neurology · 238d
Cleared Oct 25, 2013
BIOLIGHT BIODYNAM
K130866 · ILY
Biolight AB
Physical Medicine · 211d
Cleared Oct 25, 2013
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · QEY
Covidien
Cardiovascular · 207d
Cleared Oct 25, 2013
OSSEOSPEED PROFILE EV
K130999 · DZE
Dentsply Implants Manufacturing GmbH
Dental · 198d
Cleared Oct 25, 2013
BIPOLAR FORCEPS
K131058 · GEI
Boston Endo-Surgical Technologies, Inc.
General & Plastic Surgery · 192d
Cleared CT Oct 25, 2013
MIRADRY SYSTEM
K131162 · OUB
Miramar Labs, Inc.
General & Plastic Surgery · 184d
Cleared Oct 25, 2013
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K132020 · LIT
Cook, Inc.
Cardiovascular · 116d
Cleared Oct 25, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K132059 · IYN
Advanced Instrumentations, Inc.
Radiology · 114d
Cleared Oct 25, 2013
MAMMOGRAPHY VIEWER SMV658
K132188 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 102d
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM...
K132227 · JJY
Bio-Rad Laboratories
Chemistry · 100d
Cleared Oct 25, 2013
INSTINCT ENDOSCOPIC HEMOCLIP
K132809 · PKL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 46d
Cleared Oct 25, 2013
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132900 · KWP
Intelligent Implant Systems, LLC
Orthopedic · 39d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 24, 2013
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
K122295 · NHA
Core 3D Protech, S.L.
Dental · 450d
Cleared Oct 24, 2013
MAK OSS FEMORAL KNEE COMPONENTS
K131393 · KRO
Biomet Orthopedics Corp.
Orthopedic · 162d
Cleared Oct 24, 2013
LOTUS
K131427 · KWP
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Oct 24, 2013
(QUANTA SYSTEM) SURGICAL LASER FIBERS
K131473 · GEX
Quanta System Spa
General & Plastic Surgery · 155d
Cleared Oct 24, 2013
OMBRA TABLE TOP COMPRESSOR
K131881 · BTI
Trudell Medical Intl.
Anesthesiology · 121d
Cleared Oct 24, 2013
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING...
K131887 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 121d
Cleared Oct 24, 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 121d
Cleared Oct 24, 2013
ULTRACEM
K132255 · EMA
Ultradent Products Inc. / Oratech, LLC
Dental · 97d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · NBW
Delbio Incorporation
Chemistry · 90d
Cleared Oct 24, 2013
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
K132510 · HTN
Biopro, Inc.
Orthopedic · 73d
Cleared Oct 24, 2013
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS...
K132512 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 73d