Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DQY 2017-02-01

Twin-Pass Torque

Applicant Vascular Solutions, Inc.

K-Number K162467

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GEX 2017-02-01

PicoWay Laser System

Applicant Syneron Candela Corporation

K-Number K162454

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DTR 2017-02-01

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

Applicant Medtronic, Inc.

K-Number K162958

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LSR 2017-02-01

Lyme B. burgdorferi (IgG) MarStripe Test

Applicant Trinity Biotech

K-Number K163095

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PHX 2017-02-01

Exactech® Equinoxe® Preserve Stem

Applicant Exactech, Inc.

K-Number K162726

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JDR 2017-02-01

Stealth Staple System

Applicant First Ray, LLC

K-Number K163440

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JWH 2017-02-01

U2 Total Knee System, PSA Tibial Insert

Applicant United Orthopedic Corporation

K-Number K161360

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LON 2017-02-01

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

Applicant bioMerieux, Inc.

K-Number K163083

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OAP 2017-01-31

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

Applicant Capillus, LLC

K-Number K163170

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FYC 2017-01-31

Medline Non-Surgical Isolation Gown-

Applicant Medline Industries, Inc.

K-Number K160471

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LLZ 2017-01-31

NobelClinician, DTX Studio implant

Applicant Nobel Biocare AB

K-Number K163122

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LZA 2017-01-31

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

Applicant Healthy Glove Co., Ltd.

K-Number K162381

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