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

FLL 2022-01-07

Infrared Thermometer

Applicant Alicn Medical Shenzhen, Inc.

K-Number K210564

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HRS 2022-01-07

Pectus Blu Support Bar System

Applicant Biomet Micofixation

K-Number K212841

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GWF 2022-01-07

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

Applicant Inomed Medizintechnik GmbH

K-Number K212166

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OVD 2022-01-07

Tesera-k ALIF System

Applicant Kyocera Medical Technologies, Inc.

K-Number K212980

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LOX 2022-01-07

Selebrek PTCA Balloon Dilatation Catheter

Applicant Kossel Medtech (Suzhou) Co., Ltd.

K-Number K211349

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ONO 2022-01-07

Visualase MRI-Guided Laser Ablation System (SW 3.4)

Applicant Medtronic Navigation, Inc.

K-Number K211269

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GEX 2022-01-07

Picocaremajesty

Applicant Wontech Co., Ltd.

K-Number K212127

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EIH 2022-01-07

Dental Zirconia Ceramic

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K213570

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KWQ 2022-01-07

Cyclops Anterior Cervical Plate System

Applicant Degen Medical

K-Number K213901

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MEH 2022-01-07

SignaSure Dual Mobility System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K211742

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LLZ 2022-01-07

AIBOLIT 3D+

Applicant Aibolit Technologies, LLC

K-Number K211443

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QRS 2022-01-07

Sunrise Sleep Disorder Diagnostic Aid

Applicant Sunrise

K-Number DEN210015

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