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

DRE 2016-07-08

TightRail Sub-C Rotating Dilator Sheath

Applicant Spectranetics, Inc.

K-Number K161333

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OLO 2016-07-07

Styrker OrthoMap Express Knee System

Applicant Stryker Corporate

K-Number K153240

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FRG 2016-07-07

Gemini Sterilization Wrap

Applicant Medline Industries, Inc.

K-Number K152564

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OWB 2016-07-07

Cydar EV

Applicant Cydar , Ltd.

K-Number K160088

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GEI 2016-07-07

Habib EUS RFA

Applicant Emcision , Ltd.

K-Number K161305

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BZE 2016-07-07

AirLife Adult Heated Wire Circuit

Applicant Carefusion, Inc.

K-Number K153234

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NKB 2016-07-07

CorticaLINK Spinal Fusion Platform

Applicant Facetlink Dba Linkspine

K-Number K160722

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GEH 2016-07-06

Cool Renewal

Applicant Cool Renewal, LLC

K-Number K161296

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MLR 2016-07-06

V-PRO® 1 Plus and V-PRO® maX Low Temperature

Applicant STERIS Corporation

K-Number K160433

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KXK 2016-07-06

SPEC Model M13

Applicant Source Production and Equipment Co., Inc.

K-Number K161395

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LZH 2016-07-06

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

Applicant Covidien

K-Number K153074

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MWI 2016-07-06

LD-Oxi system

Applicant Ld Technology, LLC

K-Number K160956

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