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

LZA 2017-10-12

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)

Applicant Hartalega Sdn Bhd

K-Number K171874

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LCP 2017-10-12

Lucica Glycated Albumin-L

Applicant Asahi Kasei Pharma Corporation

K-Number K170147

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LNH 2017-10-12

MAGNETOM Terra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170840

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DSP 2017-10-12

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

Applicant Datascope Corp.

K-Number K172305

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KTT 2017-10-12

Galaxy UNYCO System

Applicant Orthofix Srl

K-Number K170146

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DPS 2017-10-12

Creavo Vitalscan Magnetocardiograph

Applicant Creavo Medical Technologies, Ltd.

K-Number K170154

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MAX 2017-10-11

NuVasive® Modulus XLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K172123

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FZP 2017-10-11

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

Applicant AtriCure, Inc.

K-Number K172742

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FMI 2017-10-11

Clickfine Pen Needle, Penfine Classic Pen Needle

Applicant Ypsomed AG

K-Number K171984

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HEB 2017-10-11

U by Kotex Click Unscented Menstrual Tampons

Applicant Kimberly-Clark Corporation

K-Number K172118

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CCK 2017-10-11

Nihon Kohden CO2 Monitor

Applicant Nihon Kohden Corporation

K-Number K171765

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KNT 2017-10-11

Stomach Tube

Applicant Well Lead Medical Co., Ltd.

K-Number K162340

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