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

NGX 2017-12-04

PowerDot PD-01M

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K172876

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OCW 2017-12-01

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor

Applicant Sutureease, Inc.

K-Number K172666

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HSB 2017-12-01

PRECICE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K173129

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FRO 2017-12-01

Alevicyn SG Antimicrobial Gel

Applicant Sonoma Pharmaceuticals, Inc.

K-Number K171935

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ODP 2017-12-01

ACIF

Applicant Coligne AG

K-Number K173148

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DZE 2017-12-01

S.I.N. Implant System

Applicant S.I.N. Sistema DE Implante Nacional S.A.

K-Number K170392

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GEX 2017-12-01

LightWalker Laser System Family

Applicant Fotona D.O.O.

K-Number K172819

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MAX 2017-12-01

Altus Spine Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K170553

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GEX 2017-12-01

CuRAS Nd:YAG Laser

Applicant Ilooda Co,., Ltd.

K-Number K173038

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DZE 2017-12-01

IR Type Implant System

Applicant Biotem Co., Ltd.

K-Number K171185

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IYE 2017-12-01

EZFluence

Applicant Radformation, Inc.

K-Number K171352

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GXY 2017-12-01

MR Conditional Cup Electrode, MR Conditional Webb Electrode

Applicant Rhythmlink International, LLC

K-Number K172503

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