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

GEX 2017-12-07

Q-Switched Nd:YAG Laser System

Applicant Ami, Inc.

K-Number K172908

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OWI 2017-12-07

NuVasive® VersaTie System

Applicant Nuvasive, Inc.

K-Number K173117

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FAJ 2017-12-07

Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

Applicant Henke-Sass, Wolf GmbH

K-Number K171336

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LJS 2017-12-06

C3 Wave System

Applicant Medical Components, Inc (Dba Medcomp_

K-Number K170934

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HRS 2017-12-06

OrthoPediatrics Wrist Fusion Plate

Applicant Orthopediatrics, Inc.

K-Number K172425

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KWQ 2017-12-06

Boundary Anterior Lumbar Buttress Plate

Applicant Nvision Biomedical Technologies, LLC

K-Number K173091

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NUC 2017-12-06

wettrust D2care

Applicant Wettrust Korea Co., Ltd.

K-Number K170797

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EBF 2017-12-06

BEAUTIFIL Flow Plus X

Applicant Shofu Dental Corporation

K-Number K172530

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MAX 2017-12-06

Vertera Spine Coalesce Thoracolumbar Interbody Fusion System

Applicant Nu Vasive, Incorporated

K-Number K173153

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DQY 2017-12-06

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm

Applicant Inneuroco, Inc.

K-Number K172468

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GDW 2017-12-05

Disposable Circular Stapler

Applicant Changzhou Kangdi Medical Stapler Co., Ltd.

K-Number K172561

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LPL 2017-12-05

OxyPure Color Silicone Hydrogel Soft Contact Lenses

Applicant Visco Vision, Inc.

K-Number K171447

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