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

NHA 2020-04-08

Panthera Dental Milled Bars

Applicant Panthera Dental, Inc.

K-Number K192108

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QFM 2020-04-08

AIMI-Triage CXR PTX

Applicant Radlogics, Inc.

K-Number K193300

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LHN 2020-04-08

Orfit Aerial Couchtop

Applicant Orfit Industries NV

K-Number K200282

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DQX 2020-04-08

HI-TORQUE Steelcore Bare Guide Wire

Applicant Abbott Vascular

K-Number K200144

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NKG 2020-04-07

VERTICALE® Cervical System

Applicant Silony Medical GmbH

K-Number K192013

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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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