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

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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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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KWQ 2016-03-28

TRYPTIK2C-plate Anterior Cervical Plate System

Applicant Spineart

K-Number K153042

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ODP 2016-03-28

ANATOMIC PEEK PTC Cervical Fusion System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K160528

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FLL 2016-03-28

Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

Applicant Fudakang Industries Co., Ltd.

K-Number K152640

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HWC 2016-03-28

SMV Scientific Schanz Screws

Applicant Smv Scientific

K-Number K160603

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HBG 2016-03-26

MRII Cranial Drill and Accessories

Applicant Mri Interventions, Inc.

K-Number K160129

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JAK 2016-03-25

SOMATOM Perspective

Applicant Siemens Medical Solutions USA, Inc.

K-Number K151765

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JZO 2016-03-25

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

Applicant Phadia AB

K-Number K151799

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