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

MBL 2016-12-14

OXINIUM DH Fermoral Heads

Applicant Smith & Nephew, Inc.

K-Number K161233

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CHL 2016-12-14

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)

Applicant Instrumentation Laboratory CO

K-Number K160412

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KPI 2016-12-13

HPM-6000U

Applicant BTL Industries, Inc.

K-Number K162010

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DQK 2016-12-13

AutoMark Module

Applicant St Jude Medical

K-Number K160218

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DQK 2016-12-13

EnSite Precision Cardiac Mapping System v2.0

Applicant St Jude Medical

K-Number K160210

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DRF 2016-12-13

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

Applicant St Jude Medical

K-Number K160335

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FLL 2016-12-13

Cloud Smart Thermometer

Applicant Guangzhou Bosma Technology Co, Ltd.

K-Number K160306

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FIP 2016-12-13

Matrix Pre-Treatment Controller

Applicant Better Water, LLC

K-Number K161844

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LIT 2016-12-13

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K160941

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KPR 2016-12-13

Carestream DRX-Evolution

Applicant Carestream Health, Inc.

K-Number K163203

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DQK 2016-12-13

MediGuide Technology System

Applicant St Jude Medical

K-Number K162643

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GEI 2016-12-12

InMode RF System

Applicant Inmode MD , Ltd.

K-Number K163190

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