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

DZE 2020-02-21

AR_N SLA Type Implant System

Applicant Biotem Co., Ltd.

K-Number K190641

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LNH 2020-02-21

OASIS MRI System

Applicant Hitachi Healthcare Americas

K-Number K192851

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GEX 2020-02-21

Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60

Applicant Quanta System Spa

K-Number K192600

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IYE 2020-02-21

Beamscan MR

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten

K-Number K191646

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OHT 2020-02-21

SmoothSkin Pure

Applicant Cyden Limited

K-Number K200184

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PCA 2020-02-21

Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

Applicant Life Technologies Corporation

K-Number K191030

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GXD 2020-02-21

Coolief Radiofrequency Generator (CRG) System

Applicant Avanos Medical, Inc.

K-Number K192491

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FRO 2020-02-21

Biatain Silicone Ag

Applicant Coloplast A/S

K-Number K191536

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FED 2020-02-21

PatCom Single-Use Introducer

Applicant H&A Mui Enterprises, Inc.

K-Number K192691

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PHX 2020-02-21

Glenoid Baseplate with Screw

Applicant Fx Shoulder USA, Inc.

K-Number K192799

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PGY 2020-02-21

3MP Monochrome Digital Mammography LCD Monitor MS-S300

Applicant Jvckenwood Corporation

K-Number K200161

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MAX 2020-02-21

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage

Applicant Omnia Medical, LLC

K-Number K190363

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