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

PMC 2017-04-17

Paxman Scalp Cooler

Applicant Paxman Coolers Limited

K-Number K163484

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FFX 2017-04-17

EndoFLIP® System with FLIP Topography module

Applicant Crospon, Ltd.

K-Number K170833

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IOR 2017-04-17

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

Applicant Invacare Corporation

K-Number K162621

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GWM 2017-04-17

Pressio 2 ICP Monitoring System

Applicant Sophysa SA

K-Number K162108

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PTD 2017-04-17

PowerFlow Apheresis I.V. Port

Applicant C.R. Bard, Inc.

K-Number K163001

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HJO 2017-04-14

Marco Ultra M3, Marco Ultra M4

Applicant Takagi Seiko Co., Ltd.

K-Number K162636

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OLO 2017-04-14

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163581

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KTT 2017-04-14

Hoffmann LRF System

Applicant Stryker GmbH

K-Number K163656

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NKB 2017-04-14

Fortress Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K170268

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GXY 2017-04-14

Complete Control System

Applicant Coapt, LLC

K-Number K162891

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DQK 2017-04-14

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

Applicant Edwards Lifesciences, LLC

K-Number K163381

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NBW 2017-04-14

Smart Dongle Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K162382

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