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

IYN 2017-08-03

U-Lite EXP

Applicant Sonoscanner

K-Number K171164

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LLZ 2017-08-03

Clarity Reveal

Applicant Ceevra, Inc.

K-Number K171356

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CBK 2017-08-02

731 Series Ventilators

Applicant ZOLL Medical Corporation

K-Number K162832

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MOL 2017-08-02

Skyn Original Polyisoprene Lubricated Male Condom - Flavored

Applicant Ansell Healthcare Products, LLC

K-Number K171172

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JXM 2017-08-02

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card

Applicant Healgen Scientific,, LLC

K-Number K163704

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MEG 2017-08-02

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

Applicant Yangzhou Medline Industry, Co., Ltd.

K-Number K170651

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OUR 2017-08-02

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Applicant Medacta International S.A.

K-Number K171595

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MWI 2017-08-02

Accutorr 7/VS-900 Vital Signs Monitor

Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K-Number K170712

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ETY 2017-08-02

Hearing Healthcare Pro

Applicant Db Diagnostic Systems, Inc.

K-Number K171038

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GEI 2017-08-02

AUTOCON III 400

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K171717

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PBX 2017-08-02

truSculpt

Applicant Cutera, Inc.

K-Number K172004

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ODP 2017-08-01

Calix-C Cervical Interbody Spacer

Applicant X-Spine Systems, Inc.

K-Number K171075

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