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

KPR 2021-01-06

MULTIX Impact C

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203340

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LHQ 2021-01-06

Thermidas IR System (ThIR-A615)

Applicant Thermidas Americas, Inc.

K-Number K200999

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MAX 2021-01-06

SIRION Lateral Lumbar Interbody Fusion

Applicant Astura Medical, LLC

K-Number K202495

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FXX 2021-01-06

Medical Surgical Masks-Non Sterile

Applicant Shandong T&F Nonwoven Co., Ltd.

K-Number K202594

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FXX 2021-01-06

Disposable Surgical Face Mask

Applicant Jiangsu Newvalue Medical Products Co., Ltd.

K-Number K202491

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KTT 2021-01-06

AutoStrut G2

Applicant Orthospin, Ltd.

K-Number K202810

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HTY 2021-01-06

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

Applicant OSSIO , Ltd.

K-Number K203465

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IZL 2021-01-06

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K202350

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FER 2021-01-06

Applied Medical Anoscope

Applicant Applied Medical Resources

K-Number K200021

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FYA 2021-01-06

Medical Surgical Gowns

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

K-Number K202844

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ODC 2021-01-06

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

Applicant Wilson Instruments (Sha) Co., Ltd.

K-Number K200769

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NXC 2021-01-06

NEOLab Clear Aligners

Applicant New England Ortho Lab, Inc.

K-Number K203339

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