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

DZE 2018-06-18

IU Implant System

Applicant Warantec Co., Ltd.

K-Number K172345

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LJS 2018-06-18

Sherlock 3CG+ T ip Confirmation System

Applicant C.R. Bard, Inc.

K-Number K180560

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DXN 2018-06-18

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819

Applicant Ageless Health Industrial Co., Ltd.

K-Number K172895

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EBF 2018-06-18

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

Applicant Zirkonzahn Srl

K-Number K181484

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GYC 2018-06-18

SD LTM STIM Cortical Stimulator

Applicant Micromed S.P.A.

K-Number K180761

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QEW 2018-06-17

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical, Inc.

K-Number K181325

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FYA 2018-06-15

Medline Prevention CoolZone Gown

Applicant Medline Industries, Inc.

K-Number K172954

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LNH 2018-06-15

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K173507

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HEB 2018-06-15

Interlude and private label Unscented 3-piece compact applicator tampon

Applicant Albaad Fem

K-Number K173225

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LLZ 2018-06-15

Fusion Bx 2.0

Applicant Focal Healthcare, Inc.

K-Number K181290

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NHA 2018-06-15

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K173908

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HRS 2018-06-15

CoLink Afx Plating System

Applicant In2bones USA, LLC

K-Number K181113

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