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

GEH 2017-11-21

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

Applicant Galil Medical, Inc.

K-Number K173037

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ODP 2017-11-21

Vertera Spine Cohere Cervical Interbody Fusion Device

Applicant Nu Vasive, Incorporated

K-Number K173030

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DQY 2017-11-21

TXM Support Catheter

Applicant Texasmedical Technologies, Inc.

K-Number K170914

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LCP 2017-11-21

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

Applicant Abbott Rapid Diagnostics

K-Number K171650

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KMW 2017-11-21

Surgical Angle Handpiece, Surgical Straight Handpiece

Applicant Nakanishi, Inc.

K-Number K171155

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JEY 2017-11-21

KLS Martin Individual Patient Solutions

Applicant KLS Martin L.P.

K-Number K163579

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NUC 2017-11-21

Climax Personal Lubricant

Applicant Wsm Investment, LLC, Dba Topco Sales

K-Number K171044

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EFB 2017-11-21

Dental Low-speed Turbine Handpiece

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K170236

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NGX 2017-11-20

Tyece OTC EMS System, Model EM35

Applicant Tyece , Ltd.

K-Number K172241

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DTK 2017-11-20

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

Applicant William Cook Europe Aps

K-Number K172584

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GEX 2017-11-20

Rapid Family

Applicant Sharplight Technologies, Ltd.

K-Number K173169

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LLZ 2017-11-20

syngo®.via protoNeo (Version VA20)

Applicant Siemens Healthcare GmbH

K-Number K173378

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