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

LZO 2019-10-07

PROFEMUR TL2 Stems

Applicant Microport Orthopedics, Inc.

K-Number K191632

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MBI 2019-10-05

AFX Femoral Implant with Inserter

Applicant Cayenne Medical

K-Number K192428

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QDQ 2019-10-04

ProFound AI Software V2.1

Applicant Icad, Inc.

K-Number K191994

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EZL 2019-10-04

Urethrotech UCD

Applicant Urethrotech

K-Number K190060

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PHX 2019-10-04

Delta Xtend Revers Shoulder System

Applicant Depuy(Ireland)

K-Number K192448

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LZA 2019-10-04

Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs

Applicant Semperit Investments Asia Pte , Ltd.

K-Number K183441

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DJR 2019-10-04

LZI Methadone II Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K192433

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EBG 2019-10-04

Ceramill A-Temp

Applicant Amann Girrbach AG

K-Number K191843

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CDD 2019-10-04

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

Applicant Beckman Coulter Biomedical GmbH

K-Number K190298

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MSS 2019-10-04

Bausch + Lomb PreVue Inserter for enVista Preloaded

Applicant Bausch & Lomb, Inc.

K-Number K192005

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DRA 2019-10-04

Steerable Introducer 12F

Applicant Freudenberg Medical, LLC

K-Number K192422

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EBI 2019-10-04

Tokuyama Rebase III

Applicant Tokuyama Dental Corporation

K-Number K190940

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