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

DSA 2019-09-13

Multi-Link X2 ECG and SpO2 Adapter

Applicant Vyaire Medical, Inc.

K-Number K191273

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FRC 2019-09-13

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

Applicant Terragene S.A.

K-Number K191021

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DQA 2019-09-13

Pulse Oximeter

Applicant Shenzhen Aeon Technology Co., Ltd.

K-Number K190869

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MSS 2019-09-13

UNFOLDER Vitan Inserter

Applicant Johnson & Johnson Surgical Vision, Inc.

K-Number K191949

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JAK 2019-09-13

SCENARIA View

Applicant Hitachi Healthcare Americas

K-Number K190841

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MMI 2019-09-13

ARCHITECT STAT High Sensitivity Troponin-I

Applicant Abbott Laboratories Diagnostics Division

K-Number K191595

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HRS 2019-09-13

NCB Plating System Distal Femur and Proximal Tibia

Applicant Zimmer GmbH

K-Number K192217

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MBI 2019-09-13

Arthrex Tenodesis Button

Applicant Arthrex, Inc.

K-Number K190288

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NEU 2019-09-13

RFID Localization System

Applicant Health Beacons, Inc.

K-Number K190932

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GEI 2019-09-13

NICO Myriad NOVUS

Applicant Nico Corporation

K-Number K191599

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MBI 2019-09-13

JuggerStitch Meniscal Repair Device

Applicant Biomet, Inc.

K-Number K191459

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LHN 2019-09-13

PROBEAT-CR

Applicant Hitachi , Ltd.

K-Number K191801

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