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

KTL 2018-04-20

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

Applicant Euroimmun Us, Inc.

K-Number K172252

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OMP 2018-04-20

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K180618

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JWH 2018-04-20

World Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K180750

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KGO 2018-04-20

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy

Applicant Pt. Medisafe Technologies

K-Number K173258

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KPR 2018-04-20

Televere Podiatry X-Ray System HF

Applicant Televere Systems, Inc.

K-Number K180765

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EOB 2018-04-20

Sharpsite AC Rigid Endsocope

Applicant Medtronic Xomed, Inc.

K-Number K173855

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NUJ 2018-04-20

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider

Applicant Stryker Sustainability Solutions

K-Number K180451

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HWC 2018-04-20

SafetyFix EasyOut System

Applicant Safetyfix Medical Technologies, Inc.

K-Number K180753

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IYN 2018-04-20

Viamo c100 TUS-VC100 Diagnostic Ultrasound System

Applicant Toshibamedical Systems Corporation

K-Number K173962

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LLZ 2018-04-20

Viz CTP

Applicant Viz. Ai, Inc.

K-Number K180161

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LPL 2018-04-20

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

Applicant Visco Vision, Inc.

K-Number K180322

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MQG 2018-04-20

Geri Embryo Incubator and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K-Number K180304

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