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

FMI 2016-02-02

Top Fine Pen Needle

Applicant Medexel Co.,Ltd

K-Number K152410

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HTN 2016-02-02

M-Fix Acromioclavicular Device

Applicant Coracoid Solutions, Inc.

K-Number K153211

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IYN 2016-02-02

WS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K153529

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GCJ 2016-02-01

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments

Applicant Carefusion 2200, Inc.

K-Number K151036

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HTY 2016-02-01

In2Bones Kirschner wire

Applicant In2bones Sas

K-Number K153204

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FET 2016-02-01

Image1 SPIES System

Applicant Karl Storz Endoscopy America, Inc.

K-Number K160044

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KJJ 2016-02-01

PacEndo EDTA

Applicant Pac-Dent International, Inc.

K-Number K153528

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ETN 2016-02-01

C2 NerveMonitor System

Applicant Inomed Medizintechnik GmbH

K-Number K152505

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DRA 2016-02-01

Hansen Medical Magellan Robotic Catheter eKit

Applicant Hansen Medical, Inc.

K-Number K153304

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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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