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

EBF 2016-03-02

BEAUTIFIL II Gingiva

Applicant Shofu Dental Corporation

K-Number K151700

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LXB 2016-03-02

Baha 5 Super Power Sound Processor

Applicant Cochlear Americas

K-Number K153245

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FMI 2016-03-02

Pencylcap

Applicant B.Braun Melsungen AG

K-Number K152050

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GEX 2016-03-02

PicoWay Laser System

Applicant Syneron Candela Corporation

K-Number K153527

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ODP 2016-03-02

PERIMETER C (Titanium) Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K153438

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ILY 2016-03-02

BioPhotas Celluma3

Applicant Biophotas, Inc.

K-Number K152280

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KNS 2016-03-02

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

Applicant Olympus Medical Systems Corp.

K-Number K160241

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OUR 2016-03-01

iFuse Implant System(R)

Applicant SI-BONE, Inc.

K-Number K152681

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LYZ 2016-03-01

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves

Applicant Xinfu Medical Products Co., Ltd.

K-Number K152719

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KDI 2016-03-01

xevonta dialyzer

Applicant B. Braun Avitum AG

K-Number K143482

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OLO 2016-03-01

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K153237

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MCW 2016-03-01

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

Applicant Avinger, Inc.

K-Number K153460

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