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

JWY 2018-07-03

ETEST Telavancin (TLA) (0.002-32 ug/mL)

Applicant Biomerieux S.A.

K-Number K180936

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FGB 2018-07-03

Ureterorenoscope System

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K180367

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EBF 2018-07-03

Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit

Applicant Figaro Crowns, Inc.

K-Number K172952

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PEA 2018-07-03

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

Applicant Pentax of America, Inc.

K-Number K173679

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FRO 2018-07-02

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP

Applicant Medline Industries, Inc.

K-Number K173276

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MAX 2018-07-02

Peekplus® Interbody Fusion Device

Applicant Vallum Corporation

K-Number K173864

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FTL 2018-07-02

ULTRAPRO Mesh and ULTRAPRO ADVANCED

Applicant ETHICON, Inc.

K-Number K180910

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OLV 2018-07-02

Serenity Body Position Sensor, Serenity RIP Sensors

Applicant Neurotronics, Inc.

K-Number K173868

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OLU 2018-07-01

qEEG-Pro

Applicant Brainmaster Technologies, Inc.

K-Number K171414

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DZE 2018-06-30

Zuga Dental Implant System

Applicant Zuga Medical, Inc.

K-Number K171197

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IKT 2018-06-29

Allergan Botox Needle Electrode

Applicant Natus Manufacturing Limited

K-Number K173815

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KDN 2018-06-29

Servator B SALF Solution

Applicant S.A.L.F. Spa

K-Number K180481

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