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

HTN 2018-04-03

Infinity-Lock Button System

Applicant Xiros, Ltd.

K-Number K180243

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OHS 2018-04-03

dpl IIa Panel

Applicant Led Technologies, Inc.

K-Number K180320

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MSX 2018-04-03

Unite Connect for Clinical Systems

Applicant Ascom Sweden AB

K-Number K180566

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QBH 2018-04-03

Curetis Unyvero LRT Application

Applicant Curetis GmbH

K-Number DEN170047

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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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