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
34465–34488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2015
Dentis Dental Implant System
K150344 · DZE
Dentis Co., Ltd.
Dental · 163d
Cleared Jul 24, 2015
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
K150347 · DPW
Deltex Medical Limited
Cardiovascular · 163d
Cleared Jul 24, 2015
Halo
K150486 · ONB
J & J Solutions, Inc. D/B/A/ Corvida...
General Hospital · 150d
Cleared Jul 24, 2015
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
K150906 · FTL
Ehicon, Inc.
General & Plastic Surgery · 112d
Cleared Jul 24, 2015
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
K150938 · DZE
Straumann USA, LLC
Dental · 108d
Cleared Jul 24, 2015
TRU Dental Implant System
K150968 · DZE
Sterngold Dental, LLC
Dental · 102d
Cleared Jul 24, 2015
EPX-Series Mobile X-ray System
K151038 · IZL
Ecotron Co., Ltd.
Radiology · 95d
Cleared Jul 24, 2015
TENEO Dental Treatment Unit and Accessories
K151045 · EIA
Sirona Dental Systems GmbH
Dental · 95d
Cleared Jul 24, 2015
SureLock W Suture Anchor
K151068 · MBI
Cayenne Medical, Inc.
Orthopedic · 94d
Cleared Jul 24, 2015
N-Force Fixation System
K151146 · HWC
Innovision, Inc.
Orthopedic · 86d
Cleared Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine...
K151395 · DJR
Immunalysis Corporation
Toxicology · 59d
Cleared Jul 24, 2015
Medline ENFit Connectors
K151628 · PIO
Medline Industries, Inc.
Gastroenterology & Urology · 37d
Cleared Jul 23, 2015
TRANSONIC TISSUE PERFUSION MONITOR
K140740 · DPW
Transonic Systems, Inc.
Cardiovascular · 485d
Cleared Jul 23, 2015
iuStar300 Medical Ultrasound Diagnostic System
K141720 · IYN
United Imaging Systems (Beijing) Co.,...
Radiology · 393d
Cleared Jul 23, 2015
PROTOCOL Incision Dressing
K142962 · FRO
Deroyal Industries
General & Plastic Surgery · 282d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
K143133 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 265d
Cleared Jul 23, 2015
Q6 Edge EM
K143383 · ITI
Pride Mobility Product Corporation
Physical Medicine · 240d
Cleared Jul 23, 2015
Digital Automatic Blood Pressure Monitor MD2300
K143735 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 205d
Cleared Jul 23, 2015
ORL Video NasoPharyngo-Larngoscope
K150248 · EQN
Jedmed Instrument Company
Ear, Nose, Throat · 170d
Cleared Jul 23, 2015
Muscle Stimulation System 110
K150742 · IPF
Niveus Medical, Inc.
Physical Medicine · 122d
Cleared Jul 23, 2015
E-CUBE 15 Diagnostic Ultrasound System
K150773 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 121d
Cleared Jul 23, 2015
CinchLock Flex Knotless Suture Anchor
K151314 · MBI
Pivot Medical
Orthopedic · 66d
Cleared Jul 23, 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · HRX
Medtronic, Inc.
Orthopedic · 45d
Cleared Jul 23, 2015
Magellan Robotic System
K151730 · DXX
Hansen Medical, Inc.
Cardiovascular · 27d