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

GEX 2016-10-05

CO2 Laser Therapy Machine

Applicant Beijing Adss Development Co., Ltd.

K-Number K161925

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GEH 2016-10-05

R2 Dermal Cooling System

Applicant R2 Dermatology

K-Number K161480

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HJO 2016-10-05

ALADDIN HW3.0

Applicant Visia Imaging S.R.L.

K-Number K160327

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MNI 2016-10-04

LumFix Spinal Fixation Sytem

Applicant CG Bio Co., Ltd.

K-Number K160731

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PCN 2016-10-04

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

Applicant The Binding Site Group , Ltd.

K-Number K161854

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CAZ 2016-10-04

Arrow Epidural Catheter Kit

Applicant Teleflexmedical, Inc.

K-Number K161075

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OMP 2016-10-04

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

Applicant Kci USA, Inc. (Kinetic Concepts, Inc.)

K-Number K161897

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INI 2016-10-04

ATTO Mobility Scooter

Applicant Moving Life, Ltd.

K-Number K160909

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NKB 2016-10-04

CD HORIZON® Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K162494

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MPN 2016-10-04

ACTABOND Topical Skin Adhesive

Applicant Bergen Medical Products, Inc.

K-Number K161050

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HKI 2016-10-04

Eyenez Ophthalmic Camera

Applicant Eyenez, LLC

K-Number K161727

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DZE 2016-10-03

DMi Dental Implant System

Applicant Dmi Innovative Medical Technology , Ltd.

K-Number K160060

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