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

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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LPH 2018-06-15

Trinity PLUS Acetabular Shell

Applicant Corin U.S.A. Limited

K-Number K172551

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GWE 2018-06-15

Natus Photic Stimulator

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K173936

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EGJ 2018-06-15

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

Applicant Hightech Development

K-Number K170835

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OUR 2018-06-15

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K-Number K180749

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BZD 2018-06-15

Scone Mask

Applicant Resmed, Ltd.

K-Number K180497

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