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

GDW 2018-12-07

SignalMark Lung Biopsy Site Marker

Applicant View Point Medical, Inc.

K-Number K180175

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HWC 2018-12-07

ICONN Campbell Interference Screw

Applicant Iconn Orthopedics, LLC

K-Number K180670

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MQB 2018-12-07

17HK701G-W

Applicant Lg Electronics.Inc

K-Number K183286

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CBK 2018-12-07

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, Inc.

K-Number K181695

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NKB 2018-12-07

C-Zero Pedicle Screw System, Freedom Pedicle Screw System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K180754

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MXZ 2018-12-07

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody

Applicant Leica Biosystems Newcastle, Limited

K-Number K183102

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LFL 2018-12-07

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K182809

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EBG 2018-12-07

Resin for Temporary Crown & Bridge

Applicant Dentis Co., Ltd.

K-Number K180657

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BTM 2018-12-07

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

Applicant Flexicare Medical Limited.

K-Number K181583

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OVD 2018-12-07

Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

Applicant Renovis Surgical Technologies

K-Number K182007

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KPO 2018-12-07

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)

Applicant Global Scientific Technologies, LLC

K-Number K180679

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OWB 2018-12-06

Zenition 70

Applicant Philips Medical Systems Nederland B.V.

K-Number K183040

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