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

FOZ 2020-04-07

BD Centro Vena Acute Central Line (7 French Dual Lumen)

Applicant Bard Access Systems, Inc. (Bard Has Joined Bd)

K-Number K200266

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MBH 2020-04-07

The Optimotion Blue Total Knee System

Applicant Optimotion Implants, LLC

K-Number K191084

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LNH 2020-04-07

Innovision Audio

Applicant Innovere Medical, Inc.

K-Number K193218

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MRZ 2020-04-07

BlueStar Rx

Applicant Welldoc, Inc.

K-Number K193654

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IYN 2020-04-07

HS40 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K200339

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LZA 2020-04-06

Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K200019

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NHA 2020-04-06

Straumann Screw-Retained Abutments

Applicant Straumann USA, LLC

K-Number K192401

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GGZ 2020-04-06

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K200204

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KGO 2020-04-06

SensiCare PI and SensiCare PI Micro Surgical Gloves

Applicant Medline Industries, Inc.

K-Number K193217

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DQD 2020-04-06

Eko CORE

Applicant Eko Devices, Inc.

K-Number K200776

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LTK 2020-04-06

ADVIA Centaur CA 125II

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200199

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KWQ 2020-04-06

Origin™ Anterior Cervical Plate System

Applicant Orthopaedic & Spine Development

K-Number K193494

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