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

PQZ 2017-05-16

Strep B Carrot Broth Kit

Applicant Hardy Diagnostics

K-Number K170481

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NPM 2017-05-16

DSM Biomedical Dental Bone Graft

Applicant Kensey Nash Corporation Dba Dsm Biomedical

K-Number K170245

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JDR 2017-05-16

EPIC Extremely Small Staple

Applicant Epic Extremely, LLC

K-Number K163226

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KNT 2017-05-16

Kangaroo Feeding Tube with IRIS Technology

Applicant Covidien (Dba Medtronic)

K-Number K163002

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DZE 2017-05-15

SS SA Fixture

Applicant Osstem Implant Co., Ltd.

K-Number K163557

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MQB 2017-05-15

EVS 2430W, EVS 2430GW

Applicant DRTECH Corporation

K-Number K171137

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SEL 2017-05-15

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

Applicant 3M Company

K-Number K153410

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GEX 2017-05-15

Dental 5 Multi Diode laser

Applicant Bio-Med USA, Inc.

K-Number K163638

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OHV 2017-05-15

ULTRASHAPE POWER SYSTEM

Applicant Syneron Medical, Ltd.

K-Number K170370

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JAK 2017-05-15

SPiN Thoracic Navigation System

Applicant Veran Medical Technologies, Inc.

K-Number K170023

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HIF 2017-05-15

PNEUMOCLEAR

Applicant W.O.M. World of Medicine GmbH

K-Number K170784

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HBC 2017-05-15

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

Applicant Medtronic Powered Surgical Solutions

K-Number K170312

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