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

ITX 2016-03-04

Sheathes Ultrasound Probe Covers

Applicant Sheathing Technologies, Inc.

K-Number K153212

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LPL 2016-03-04

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

Applicant Smart Performer Corp. , Ltd.

K-Number K151847

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LFL 2016-03-04

HARMONIC HOOK

Applicant Ethicon Endo-Surgery, LLC

K-Number K151136

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ELW 2016-03-04

Aquasil Ultra + Smart Wetting Impression Material

Applicant Dentply International, Inc.

K-Number K152861

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LLZ 2016-03-04

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K-Number K160426

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FLL 2016-03-04

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

Applicant Securus,Inc

K-Number K152402

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DYB 2016-03-04

Endophys Pressure Sensing Sheath Kit

Applicant Endophys, Inc.

K-Number K160272

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NHA 2016-03-04

LOCATOR F-Tx Attachment System

Applicant Zest Anchors, LLC

K-Number K151789

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PCC 2016-03-04

Cefaly

Applicant Cefaly Technology

K-Number K160237

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DQY 2016-03-04

ASAHI Corsair Armet

Applicant Asahi Intecc Co., Ltd.

K-Number K152249

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HIF 2016-03-04

Insufflator 50L FM134

Applicant W.O.M. World of Medicine GmbH

K-Number K153513

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LEJ 2016-03-04

Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5

Applicant Sun Capsule, Inc.

K-Number K152238

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