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
40153–40176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
K131206 · PFJ
Cook, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 27, 2013
EASY-GRAFT
K131385 · LYC
Degradable Solutions AG
Dental · 136d
Cleared Sep 27, 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · KWS
Materialise NV
Orthopedic · 120d
Cleared Sep 27, 2013
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 116d
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Arthrex, Inc.
Orthopedic · 115d
Cleared Sep 27, 2013
TRINITY ACETABULAR SYSTEM
K131647 · LZO
Corin USA
Orthopedic · 114d
Cleared Sep 27, 2013
MORCELLEX SIGMA GENERATOR
K131656 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 113d
Cleared Sep 27, 2013
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
K131860 · JOP
Us Vascular, LLC
Cardiovascular · 95d
Cleared Sep 27, 2013
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · DYB
Medtronic, Inc.
Cardiovascular · 88d
Cleared Sep 27, 2013
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
K132252 · OMP
Devon Medical
General & Plastic Surgery · 70d
Cleared Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · DXX
Hansen Medical, Inc.
Cardiovascular · 59d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST...
K132630 · DJC
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659 · DQY
Volcano Corporation
Cardiovascular · 32d
Cleared Sep 27, 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · DQA
GE Healthcare Finland Oy
Anesthesiology · 29d
Cleared Sep 27, 2013
NMI COAXIAL MICROINTRODUCER SET
K132713 · DRE
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · NQN
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · NBW
Bayer Healthcare
Chemistry · 416d
Cleared Sep 26, 2013
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K124043 · HQF
Lightmed Corp.
Ophthalmic · 272d
Cleared Sep 26, 2013
TCM MASSAGER
K130150 · NUH
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
Neurology · 247d
Cleared Sep 26, 2013
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
K130275 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 234d
Cleared Sep 26, 2013
PRECISION ONE LIFECARE
K130952 · MNW
Precision One Lifecare, Ltd.
Gastroenterology & Urology · 174d
Cleared Sep 26, 2013
GENII ARC SMART ARGON PROBE
K130983 · GEI
Genii, Inc.
General & Plastic Surgery · 170d
Cleared Sep 26, 2013
TRANSCEND HEATED HUMIDIFIER
K131388 · BTT
Somnetics International, Inc.
Anesthesiology · 135d
Cleared Sep 26, 2013
COSEAL
K131411 · DXC
Jilin Coronado Medical , Ltd.
Cardiovascular · 134d