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
32161–32184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2016
Cervical Interbody Fusion System
K160324 · ODP
Evolution Spine, LLC
Orthopedic · 90d
Cleared May 05, 2016
Certex Spinal Fixation System
K160428 · NKG
X-Spine Systems, Inc.
Orthopedic · 79d
Cleared May 05, 2016
Philips Efficia CMS200 Central Monitoring System
K160951 · MHX
Philips Medical Systems
Cardiovascular · 30d
Cleared May 05, 2016
Alma Diode Tabletop Laser
K160952 · GEX
Alma, Ltd.
General & Plastic Surgery · 30d
Cleared May 05, 2016
HydroMARK Breast Biopsy Site Marker
K161021 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 23d
Cleared May 05, 2016
LOGIQ P9 and LOGIQ P7
K161047 · IYN
Ge Healthcare
Radiology · 22d
Cleared May 04, 2016
6200 Ultrasound System and 6250 Ultrasound System
K153277 · IYN
Esaote, S.P.A.
Radiology · 174d
Cleared May 04, 2016
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
K153783 · MAX
Spinevision S.A.
Orthopedic · 125d
Cleared May 04, 2016
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit...
K160006 · MQL
Irvine Scientific
Obstetrics & Gynecology · 121d
Cleared May 04, 2016
Vented Vial Adapter Transfer Device - 13mm
K160503 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 70d
Cleared May 04, 2016
Precision Spine Interspinous Plate System
K160568 · PEK
Precision Spine, Inc.
Orthopedic · 65d
Cleared May 04, 2016
Electrosurgical Generator ESG-200
K160639 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 58d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654 · KNT
Covidien, LLC
Gastroenterology & Urology · 57d
Cleared May 04, 2016
Yarlap II
K160773 · KPI
International Trade Group, Inc.
Gastroenterology & Urology · 44d
Cleared May 04, 2016
Certus 140 2.45GHz Ablation System
K160936 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 30d
Cleared May 04, 2016
Xenco Medical Pedicle Screw System
K160986 · NKB
Xenco Medical, LLC
Orthopedic · 26d
Cleared May 04, 2016
Soehendra Stent Retriever
K161203 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 6d
Cleared May 03, 2016
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010,...
K152029 · BTT
Hamilton Medical AG
Anesthesiology · 286d
Cleared May 03, 2016
UCP COMPACT DRUG TESTS
K152908 · DKZ
Ucp Biosciences, Inc.
Toxicology · 215d
Cleared May 03, 2016
ENZA Zero-Profile Anterior Interbody Fusion
K153720 · OVD
Camber Spine Technologies
Orthopedic · 127d
Cleared May 03, 2016
SERFAS 90-S Electrosurgical Probe
K160050 · GEI
Stryker Corporation
General & Plastic Surgery · 113d
Cleared May 03, 2016
Swan Ganz Catheters
K160084 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 109d
Cleared May 03, 2016
STROPP (Single Tunnel Repair of Plantar Plate)
K160118 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 105d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 36d