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

MNI 2016-02-01

YAHUA Spinal System

Applicant Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.

K-Number K152324

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GIS 2016-01-31

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

Applicant Diazyme Laboratories

K-Number K143470

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DRM 2016-01-30

ROSC-U Mini Chest Compressor (RMCC)

Applicant Resuscitation International, LLC

K-Number K153628

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NKG 2016-01-29

PASS OCT Patient Specific Rods

Applicant Medicrea International

K-Number K153169

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HRS 2016-01-29

TriMed Humeral Supracondylar Fixation System

Applicant TriMed, Inc.

K-Number K151735

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BSK 2016-01-29

IntelliCuff

Applicant Hamilton Medical AG

K-Number K150893

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NKB 2016-01-29

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System

Applicant Orthofix, Inc.

K-Number K153428

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GWN 2016-01-29

EYE-SYNC

Applicant Syncthink, Inc.

K-Number K152915

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ELC 2016-01-29

Sonendo Gentle Wave System

Applicant Sonendo, Inc.

K-Number K153157

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LCP 2016-01-29

URight Hemoglobin A1c system, FORA A1c System

Applicant Taidoc Technology Corporation

K-Number K142664

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OVE 2016-01-29

COALITION Spacers

Applicant Globus Medical, Inc.

K-Number K151939

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IYE 2016-01-29

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

Applicant Scandidos AB

K-Number K151426

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