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

DSH 2016-10-13

Bioflux Software

Applicant Biotricity, Inc.

K-Number K162571

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OMP 2016-10-13

VT·One, VT·One 60days

Applicant Carilex Medical, Inc.

K-Number K161410

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LPL 2016-10-13

AIR OPTIX COLORS

Applicant Alcon Laboratories, Inc.

K-Number K162596

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DQX 2016-10-13

Sunmed Haemostatic Valves

Applicant Sunny Medical Device (Shenzhen) Co., Ltd.

K-Number K153685

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NUH 2016-10-13

OTC TENS Device, Model PTS-IV

Applicant Counter Scientific Development (Gz), Ltd.

K-Number K161537

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GEI 2016-10-12

Spetzler Malis Dual Illuminating Bipolar Forceps

Applicant Synergetics

K-Number K160103

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KRH 2016-10-12

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

Applicant Genesee Biomedical, Inc.

K-Number K161815

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PKL 2016-10-12

FTRD System Set

Applicant Ovesco Endoscopy AG

K-Number K153550

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LPL 2016-10-12

Toricolors (hioxifilcon D) Soft Contact Lenses

Applicant Polydev , Ltd.

K-Number K161931

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HRS 2016-10-12

Ulna Plating System

Applicant Biomet, Inc.

K-Number K162424

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OLO 2016-10-12

Stryker OrthoMap Precision Knee system

Applicant Stryker Leibinger GmbH & Co KG

K-Number K162341

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DTE 2016-10-12

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K-Number K162550

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