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

OVD 2016-08-29

INDEPENDENCE MIS Spacers

Applicant Globus Medical, Inc.

K-Number K160597

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KWS 2016-08-29

Arthrex VaultLock Glenoid

Applicant Arthrex, Inc.

K-Number K161108

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OMP 2016-08-29

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large

Applicant Lc Medical Concepts, Inc.

K-Number K161570

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FRO 2016-08-29

USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles

Applicant Strukmyer Medical, LLC

K-Number K161311

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NHA 2016-08-29

ATLANTIS Abutment for HIOSSEN ET implant

Applicant Dentsply Sirona

K-Number K160626

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FMI 2016-08-29

Insulin Pen Needle

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K153706

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HGX 2016-08-29

Philips Avent Comfort Single/Twin Electric Breast Pump

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K-Number K161532

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FFK 2016-08-29

UreTron PF Series Probe

Applicant Med-Sonics Corp.

K-Number K162119

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BTM 2016-08-29

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

Applicant Ambu A/S

K-Number K152931

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GXI 2016-08-26

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

Applicant Lccs Products Limited

K-Number K152642

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BZG 2016-08-26

Vitalograph Model 6300 micro

Applicant Vitalograph (Ireland) , Ltd.

K-Number K160253

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NHA 2016-08-26

ATLANTIS Abutment for CONELOG implant

Applicant Dentsply Sirona

K-Number K161030

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