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

BZD 2016-05-13

AirFit F20

Applicant Resmed, Ltd.

K-Number K153563

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ODP 2016-05-13

ALTA Anterior Cervical Interbody Spacer

Applicant Astura Medical

K-Number K160154

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FTL 2016-05-13

Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay

Applicant C.R. Bard, Inc.

K-Number K153236

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BXN 2016-05-13

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

Applicant Easy Med Instrument Co., Ltd.

K-Number K153045

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MYF 2016-05-13

SeraQuest HSV Type 2 Specific IgG

Applicant Quest International, Inc.

K-Number K152353

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DQY 2016-05-12

Guiding Catheter

Applicant Texasmedical Technologies, Inc.

K-Number K153703

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KCT 2016-05-12

ReNew Sterilization Trays(Catalog #3708 and #3709)

Applicant Microline Surgical, Inc.

K-Number K152745

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DYB 2016-05-12

GORE DrySeal Flex Introducer Sheath

Applicant W. L. Gore & Associates, Inc.

K-Number K160254

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JOJ 2016-05-12

VERIFY STEAM Integrating Indicator

Applicant STERIS Corporation

K-Number K152630

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HKI 2016-05-12

LSFG-NAVI

Applicant Softcare Co., Ltd.

K-Number K153239

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PNR 2016-05-12

Monoject Enteral Feeding Syringe with ENFit Connector

Applicant Covidien

K-Number K160419

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OAP 2016-05-12

Laser Helmet LH40-EVO

Applicant Theradome, Inc.

K-Number K161046

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