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

OKP 2016-08-23

sTMS mini

Applicant Eneura, Inc.

K-Number K161663

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KMF 2016-08-23

Cavilon Advanced High Endurance Skin Protectant

Applicant 3M Healthcare

K-Number K153571

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MEH 2016-08-22

H-Max S stem

Applicant Lima Corporate S.P.A.

K-Number K160011

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NKG 2016-08-22

Streamline OCT Occipito-Cervico-Thoracic System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K161498

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LPL 2016-08-22

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Applicant Joowon Innovation Co., Ltd.

K-Number K161098

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MNI 2016-08-22

Double Medical Universal Spine System

Applicant Double Medical Technology, Inc.

K-Number K151458

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NKB 2016-08-22

PathLoc-L MIS Spinal System

Applicant L&K BIOMED Co., Ltd.

K-Number K161766

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POM 2016-08-22

ImPACT Computerized Neurocognitive Concussion Management Aid

Applicant Impact Applications, Inc.

K-Number DEN150037

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EBZ 2016-08-22

Premium Plus C01/C02 LED Curing Light

Applicant Premium Plus International Limited

K-Number K153514

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GEI 2016-08-22

Werewolf RF20000 Controller, FLOW 50 Wand

Applicant ArthroCare Corporation

K-Number K162074

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FRO 2016-08-19

Microcyn Plus Wound Care Solution

Applicant Oculus Innovative Sciences

K-Number K161034

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NBW 2016-08-19

iHealth Align Gluco-Monitoring system

Applicant Andon Health Co, Ltd.

K-Number K153286

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