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

PNG 2016-11-03

PleurX Peritoneal Catheter System

Applicant Care Fusion

K-Number K160437

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ELW 2016-11-03

Vonflex S

Applicant Vericom Co., Ltd.

K-Number K152615

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LZA 2016-11-02

Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K162095

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GEI 2016-11-02

joimax Electrosurgical Instruments

Applicant Joimax GmbH

K-Number K161378

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NLH 2016-11-02

Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K160421

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DPS 2016-11-02

CARDIOLINE touchECG

Applicant Cardioline S.P.A

K-Number K160746

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GXQ 2016-11-02

Durepair Dura Regeneration Matrix

Applicant Medtronic Neurosurgery

K-Number K161370

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DQY 2016-11-02

Boosting Catheter

Applicant Qxmedical, LLC

K-Number K160561

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GEX 2016-11-02

Lucid Q-PTP / HWA 55

Applicant Bison Medical Co, Ltd.

K-Number K161670

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IYN 2016-11-01

Xario 200 Diagnostic Ultrasound System V5.0

Applicant Toshibamedical Systems Corporation

K-Number K162155

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LZO 2016-11-01

Initia Total Hip System & BIOCERAM AZUL(R) HEAD

Applicant Kyocera Medical Corporation

K-Number K160895

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NGX 2016-11-01

SLENDERTONE® Connect Abs, Type 570

Applicant Bio-Medical Research, Ltd.

K-Number K161974

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