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

LZA 2021-08-20

Medical Gloves

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K203622

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MAX 2021-08-20

IO Expandable Lumbar Interbody Fusion System

Applicant MiRus, LLC

K-Number K210800

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NKB 2021-08-20

MOSS VRS Spinal System

Applicant Biedermann Motech GmbH & Co. KG

K-Number K203607

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OQG 2021-08-20

Prime and DYNASTY® Additive Manufacturing Shells

Applicant Microport Orthopedics, Inc.

K-Number K202705

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QLQ 2021-08-20

Simplify Disc

Applicant Nuvasive, Inc.

K-Number K211757

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MPA 2021-08-20

Nam illumination probe with chopper

Applicant Oculight , Ltd.

K-Number K202670

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QQB 2021-08-20

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number DEN190056

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KPS 2021-08-20

Discovery MI Gen2

Applicant Ge Medical Systems, LLC

K-Number K211846

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HRS 2021-08-20

Omni Foot and Ankle Plating System

Applicant Extremity Medical, LLC

K-Number K212297

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HWC 2021-08-20

Auxilock Titanium Interference Screw

Applicant Auxein Medical Private Limited

K-Number K203029

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PHX 2021-08-20

Inset Reverse Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K210533

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FRA 2021-08-20

Molekule Air Pro

Applicant Molekule, Inc.

K-Number K211194

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