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

KCY 2017-02-16

T-Cuff

Applicant Terumobct, Inc.

K-Number K162365

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OVE 2017-02-16

Spine Wave Anterior Cervical Spine System

Applicant Spine Wave, Inc.

K-Number K162760

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MRW 2017-02-16

ALLY Facet Screws

Applicant Providence Medical Technology, Inc.

K-Number K163374

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HJO 2017-02-16

SLIT LAMP, Model: YF-100

Applicant Chongqing Yeasn Science-Technology Co., Ltd.

K-Number K161764

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JOW 2017-02-16

RF1400 Active Compression Wrap

Applicant Recovery Force, LLC

K-Number K162481

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PGW 2017-02-16

Fiagon Navigation PointerTube Straight and PointerTube Keat

Applicant Fiagon GmbH

K-Number K163416

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KWQ 2017-02-16

Kepler I Cervical Plate System

Applicant Orbbo Surgical, LLC

K-Number K163602

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MLR 2017-02-16

STERRAD NX Sterilizer

Applicant Advanced Sterilization Products

K-Number K162007

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FTM 2017-02-16

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

Applicant Tei Biosciences, Inc.

K-Number K162965

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PEK 2017-02-16

Huvex Interspinous Fixation System

Applicant Dio Medical Co., Ltd.

K-Number K162849

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MQV 2017-02-16

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

Applicant Amend Surgical, Inc.

K-Number K161996

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PRJ 2017-02-16

TAP Blood Collection Device

Applicant Seventh Sense Biosystems, Inc.

K-Number K161521

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