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

GEI 2016-04-05

Barrx FLEX RFA Energy Generator

Applicant Covidien, LLC

K-Number K160360

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IYN 2016-04-05

SonoSite SII Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K160734

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NLM 2016-04-05

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

Applicant Surgical Instrument Service and Savings (Dba Medline Renewal

K-Number K153258

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GEX 2016-04-05

EVO platform

Applicant Quanta System Spa

K-Number K160368

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EOB 2016-04-05

ULTRA Telescopes

Applicant Olympus Winter & Ibe GmbH

K-Number K153009

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DSA 2016-04-05

Disposable Temporary Pacing Cable

Applicant Tiger Medical Products

K-Number K152947

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PIF 2016-04-05

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE

Applicant Gbuk Enteral Limited

K-Number K151503

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EMA 2016-04-05

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

Applicant Gaia Dental Products, Inc.

K-Number K152652

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GEI 2016-04-05

Non-Telescopic PenEvac

Applicant I.C Medical, Inc.

K-Number K160160

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BZD 2016-04-05

SleepWeaver Advance Pediatric Nasal CPAP Mask

Applicant Circadiance, LLC

K-Number K151683

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JOW 2016-04-04

Hydroven 12, Hydroven 12 Garments

Applicant Huntleigh Healthcare , Ltd.

K-Number K152228

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MEB 2016-04-04

SMARTez elastomeric infusion pump

Applicant Epic Medical Pte. , Ltd.

K-Number K151650

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