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

DZE 2017-09-28

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm

Applicant Sterngold Dental, LLC

K-Number K171728

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ORC 2017-09-28

SurgiCube

Applicant Surgicube International B.V.

K-Number K163455

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MBI 2017-09-28

FiberTak DX

Applicant Arthex, Inc.

K-Number K172612

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OLP 2017-09-28

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

Applicant Li-Tek Electronics Technologies

K-Number K161434

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DYB 2017-09-28

Peel-Away Introducer Set

Applicant Cook Incorporated

K-Number K170020

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KTT 2017-09-27

Spider Frame External Fixation System

Applicant Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S

K-Number K170482

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LGZ 2017-09-27

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K-Number K171215

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GEH 2017-09-27

CRYOFOS

Applicant Cryofos Medical GmbH

K-Number K170810

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KTT 2017-09-27

OIC External Fixation System

Applicant Orthopaedic Implant Company

K-Number K171211

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JWY 2017-09-27

Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K172109

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DSH 2017-09-27

Peerbridge Cor(TM) System

Applicant Peerbridge Health, Inc.

K-Number K171936

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NKB 2017-09-27

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System

Applicant Zimmer Biomet Spine, Inc.

K-Number K172275

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