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

KZH 2017-07-26

Orbit Inserter

Applicant Ypsomed AG

K-Number K163400

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LLZ 2017-07-26

BiopSee, Mobile US

Applicant Medcom GmbH

K-Number K170841

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FLL 2017-07-26

wireless thermometer

Applicant Ech (Changzhou) Medical Instrument Co., Ltd.

K-Number K170769

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MAX 2017-07-25

LumFuse-TP

Applicant Precifit Medical, Ltd.

K-Number K171630

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LZA 2017-07-25

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

Applicant Shen Wei USA, Inc.

K-Number K162312

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FMJ 2017-07-25

Spinal Manometer NRFit; Spinal Manometer LUER

Applicant PAJUNK GmbH Medizintechnologie

K-Number K170305

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IYE 2017-07-25

HP PRO Positioning Device

Applicant Orfit Industries NV

K-Number K171734

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DYB 2017-07-25

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

Applicant Biosense Webster, Inc.

K-Number K170997

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PKL 2017-07-25

FTRD System Set

Applicant Ovesco Endoscopy AG

K-Number K170867

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MBI 2017-07-25

ANCHORMAN Tibial Ligament Fixation Device

Applicant Summit Medical , Ltd.

K-Number K170388

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HQF 2017-07-25

Easyret

Applicant Quantel Medical

K-Number K170067

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DQY 2017-07-25

Rubicon 14, 18 and 35 Support Catheters

Applicant Boston Scientific Corporation

K-Number K171913

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