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

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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IYN 2016-03-25

LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K160277

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PAM 2016-03-25

Great Basin Staph ID/R Blood Culture Panel

Applicant Great Basin Scientific, Inc.

K-Number K152470

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JWH 2016-03-25

iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K-Number K153721

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MAX 2016-03-25

SurgTech Interbody System

Applicant Surgtech, Inc.

K-Number K152200

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FZP 2016-03-25

Vas-Q-Clip

Applicant Nanova Biomaterials, Inc.

K-Number K151943

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