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

PDU 2016-05-24

CROSSER CTO Recanalization Catheter

Applicant Bard Peripheral Vacular, Inc.

K-Number K161208

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CAC 2016-05-24

Haemonetics Cell Saver Elite Autotransfusion System

Applicant Haemonetics Corporation

K-Number K160197

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GCJ 2016-05-23

PINPOINT Endoscopic Fluorescence Imaging System

Applicant Novadaq Technologies, Inc.

K-Number K150956

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FRO 2016-05-23

Agem Ag Mesh Dressing with Silver

Applicant Shenzhen Yuanxing Nano-Pharma Co., Ltd.

K-Number K152544

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JXM 2016-05-23

Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

Applicant Healgen Scientific,, LLC

K-Number K153597

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DZE 2016-05-23

INCLUSIVE TAPERED IMPLANT SYSTEM

Applicant Prismatik Dentalcraft, Inc.

K-Number K153099

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LCJ 2016-05-23

ARTOURA Breast Tissue Expanders with Smooth Surface

Applicant Mentor Worldwide, LLC

K-Number K161176

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EBF 2016-05-20

everX Posterior

Applicant GC America, Inc.

K-Number K153127

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OAS 2016-05-20

Planmeca ProMax 3D Max, Planmeca Maximity

Applicant Planmeca Oy

K-Number K160506

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MAX 2016-05-20

Reliance Lumbar IBF System

Applicant Reliance Medical Systems, LLC

K-Number K160463

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JIX 2016-05-20

VITROS Chemistry Products Calibrator Kit 3

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K161140

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IOR 2016-05-20

Kudu

Applicant R82 A/S

K-Number K151492

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