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

CBK 2016-03-30

Flight 60 Ventilator

Applicant Flight Medical Innovations , Ltd.

K-Number K143035

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KPR 2016-03-30

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

Applicant Visaris D.O.O. Belgrade

K-Number K160620

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LLZ 2016-03-29

Synaptive ImageDrive Pro

Applicant Synaptive Medical, Inc.

K-Number K153284

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DXN 2016-03-29

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K160336

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GEX 2016-03-29

PURE CRYOGEN

Applicant Air Liquide Healthcare America Corporation

K-Number K153564

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EIH 2016-03-29

X-cera Zirconia Blanks

Applicant Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.

K-Number K153767

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LNH 2016-03-29

SIGNAPioneer

Applicant GE Healthcare

K-Number K160621

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PNG 2016-03-29

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set

Applicant Rocket Medical Plc

K-Number K152105

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CBK 2016-03-29

Puritan Bennett 840 Series Ventilator System

Applicant Covidien LP

K-Number K151252

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PMN 2016-03-28

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

Applicant Bio-Rad Laboratories

K-Number DEN150058

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LFL 2016-03-28

Sonicision Cordless Ultrasonic Dissection Device

Applicant Covidien, LLC

K-Number K153371

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LPL 2016-03-28

ACUVUE (senofilcon C) Soft Contact Lens

Applicant Johnson & Johnson Vision Care, Inc.

K-Number K160212

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