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

LZA 2020-06-19

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K192954

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LZA 2020-06-19

Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for

Applicant Ansell Healthcare Products, LLC

K-Number K200671

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NHA 2020-06-19

TruAbutment DS

Applicant Truabutment, Inc.

K-Number K191913

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MAX 2020-06-19

SpineFrontier Lumbar Interbody Fusion Device System

Applicant Spinefrontier, Inc.

K-Number K193106

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LZO 2020-06-19

Cemented TSI Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K192024

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LFL 2020-06-19

Kogent Torus Ultrasonic Aspirator

Applicant Katalyst Surgical, LLC

K-Number K192963

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QAS 2020-06-19

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K193298

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DZE 2020-06-19

Fit & Brilliant Dental Implant System

Applicant F&B Technology Co., Ltd.

K-Number K190637

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MRN 2020-06-19

The NOxBOXi Nitric Oxide Delivery System

Applicant Praxair, Inc.

K-Number K201339

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FLL 2020-06-19

Infrared Thermometer Model Number RN-60A,RN-60B

Applicant Ningbo Ranor Medical Science & Technology Co., Ltd.

K-Number K200471

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DXN 2020-06-18

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K200297

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CBK 2020-06-18

Servo-air 4.0 Ventilator System

Applicant Maquet Critica Care AB

K-Number K192604

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