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

IYE 2018-04-06

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung

Applicant Varian Medical Systems, Inc.

K-Number K170570

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OLO 2018-04-06

NAVIO™ Surgical System (NAVIO system)

Applicant Blue Belt Technologies, Inc.

K-Number K180271

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OMP 2018-04-06

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K180614

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CCT 2018-04-06

Medicant Mucosal Atomizer

Applicant Medica Holdings, LLC

K-Number K172956

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MQV 2018-04-06

FIBERGRAFT BG Matrix Bone Graft Substitute

Applicant Prosidyan, Inc.

K-Number K180080

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LLZ 2018-04-05

uWS-MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K172998

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OXF 2018-04-05

GORE ENFORM Biomaterial

Applicant W. L. Gore & Associates, Inc.

K-Number K173333

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KRA 2018-04-05

VAMP Venous/Arterial Blood Management Protection System

Applicant Edwards Lifesciences, LLC

K-Number K173586

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KCT 2018-04-05

Neodent Instrument Kits

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K171713

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EBD 2018-04-05

Nano Varnish, Plaquit, Lightpaint on Surface

Applicant Dreve Dentamid GmbH

K-Number K162408

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LLZ 2018-04-05

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173897

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PHX 2018-04-05

Medacta Shoulder System Short Humeral Diaphysis

Applicant Medacta International S.A.

K-Number K180089

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