Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NKB 2018-04-06

Patriot Spinal Fixation System

Applicant Valorus Spine

K-Number K180324

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NAY 2018-04-06

8mm Monopolar Curved Scissors

Applicant Intuitive Surgical, Inc.

K-Number K180033

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NBY 2018-04-06

PTFE SURGICAL SUTURE

Applicant Omnia Spa

K-Number K180630

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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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