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

DZE 2018-04-03

Kisses Plus Implant System

Applicant Achimhai Medical Corporation

K-Number K172630

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DQO 2018-04-03

High-Flo Silver Polyethylene Catheter

Applicant Cook Incorporated

K-Number K172635

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KWQ 2018-04-03

Genesys Spine Binary Lumbar Plate System

Applicant Genesys Spine

K-Number K173885

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DQO 2018-04-03

Surefire Spark Infusion System

Applicant Surefire Medical, Inc.

K-Number K180677

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LPL 2018-04-03

OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens

Applicant Visco Vision, Inc.

K-Number K173958

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FRO 2018-04-02

Microcyn Antimicrobial Hydrogel

Applicant Sonoma Pharmaceuticals, Inc.

K-Number K173896

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IYE 2018-04-02

Varian Head Frame

Applicant Varian Medical Systems, Inc.

K-Number K180586

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OWB 2018-04-02

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K173639

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NKB 2018-04-02

CREO® Stabilization System

Applicant Globus Medical, Inc.

K-Number K180210

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LXV 2018-04-02

K-D Balance

Applicant King-Devick Technologies, Inc.

K-Number K173669

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KCT 2018-04-02

Instrument basket, for EndoEYE

Applicant Olympus Winter & Ibe GmbH

K-Number K171692

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EMA 2018-04-02

GC Fuji Direct

Applicant GC America, Inc.

K-Number K172382

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