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

QSY 2017-01-18

Bondiloxs Topical Hemostatic Granules

Applicant Medtrade Products , Ltd.

K-Number K161274

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HWC 2017-01-18

GEO Bone Screw System

Applicant Gramercy Extremity Orthopeidics, LLC

K-Number K161904

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GZJ 2017-01-18

STIMPOD NMS460 Nerve Stimulator

Applicant Xavant Technology (Pty), Ltd.

K-Number K161091

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MOS 2017-01-18

Breast BI 7 MR Coil Mammavention 3T

Applicant Moras Mri Products GmbH

K-Number K162651

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MMI 2017-01-18

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

Applicant Roche Diagnostics

K-Number K162895

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MQV 2017-01-18

NovaBone IRM

Applicant Novabone Products, LLC

K-Number K163310

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EQJ 2017-01-17

Precision Thin Reciprocating Blade, 0.010in.

Applicant Stryker Corporation

K-Number K161514

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KHE 2017-01-17

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

Applicant Immunostics Inc.,

K-Number K163554

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GZJ 2017-01-17

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

Applicant Well-Life Healthcare Limited

K-Number K162663

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PHX 2017-01-17

Humelock Reversed Shoulder

Applicant Fx Solutions

K-Number K162455

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LIT 2017-01-17

Chameleon PTA Balloon Catheter

Applicant Av Medical Technologies, Ltd.

K-Number K163231

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HGH 2017-01-13

PANPAC DISPOSABLE VACUUM CURETTES

Applicant Panpac Medical Corporation

K-Number K161106

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