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

GCJ 2020-08-06

Disposable Laparoscope Trocar

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K201641

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OAS 2020-08-06

Midmark Extraoral Imaging System (EOIS)

Applicant Midmark Corporation

K-Number K201667

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KCT 2020-08-06

Steripack cases and Tray Systems

Applicant Avalign Technologies, Inc.

K-Number K193066

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CAW 2020-08-06

Invacare Perfecto2V Oxygen Concentrator

Applicant Invacare Corporation

K-Number K200890

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QJP 2020-08-06

Anchor Dual Lumen Guidewire Catheter

Applicant Aqure Medical, Inc.

K-Number K201076

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KCT 2020-08-06

Mini Sterilizable Tray

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K200858

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DQY 2020-08-06

NHancer Rx

Applicant Imds Operations B.V.

K-Number K200324

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KWQ 2020-08-06

Medina Anterior Cervical Plate System

Applicant Alliance Partners, LLC

K-Number K201521

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MTD 2020-08-06

Pentaray Nav eco High-Density Mapping Catheter

Applicant Biosense Webster, Inc.

K-Number K201750

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FTL 2020-08-06

VICRYL Mesh

Applicant ETHICON, Inc.

K-Number K201143

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LZA 2020-08-05

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K201530

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KWQ 2020-08-05

Aurora® Anterior Lumbar Plate Sytstem

Applicant Prism Surgical Design Pty , Ltd.

K-Number K201079

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