Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DTZ 2017-10-25

Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir

Applicant Medtronic, Inc.

K-Number K172626

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MAX 2017-10-25

Ortus Expandable Lumbar Interbody Fusion System

Applicant Atlas Spine, Inc.

K-Number K172334

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MWI 2017-10-25

3880 MRI Patient Monitoring System

Applicant Iradimed Corporation

K-Number K172200

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FTM 2017-10-25

Colorado Therapeutics Xenograft Implant

Applicant Colorado Therapeutics, LLC

K-Number K172937

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NFO 2017-10-25

Smart Photon Micro-current Device, Model: EP-300

Applicant Li-Tek Electronic Technology Corporation

K-Number K162652

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MQB 2017-10-24

Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)

Applicant Varex Imaging Corporation

K-Number K172951

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HQD 2017-10-24

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K-Number K171575

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MWI 2017-10-24

SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module

Applicant Capsule Technologie Sas

K-Number K171751

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QEZ 2017-10-24

ClearLumen II Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K-Number K172000

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CGZ 2017-10-24

Alinity c ICT Sample Diluent

Applicant Abbott Laboratories

K-Number K170320

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OWB 2017-10-24

Dynamic Coronary Roadmap 2.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K172307

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LPH 2017-10-24

UTS Stem

Applicant United Orthopedic Corporation

K-Number K172251

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