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

GEX 2021-10-26

Medical Diode Laser Systems

Applicant Wuhan Dimed Laser Technology Co., Ltd.

K-Number K211977

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QEZ 2021-10-26

Thrombuster II Aspiration Catheter

Applicant Kaneka Medical America, LLC

K-Number K213166

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NXC 2021-10-26

QuickAligners

Applicant Oral Image, Inc.

K-Number K211537

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PHX 2021-10-26

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres

Applicant Tornier, Inc.

K-Number K213124

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LRK 2021-10-26

EndSnorZ Sleep Appliance

Applicant Prismatik Dentalcraft, Inc.

K-Number K211069

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LZA 2021-10-25

Disposable Nitrile Examination Glove

Applicant Inner Mongolia Cureguard Medical Technology Co., Ltd.

K-Number K212401

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GEI 2021-10-25

Ultrasonic Surgical & Electrosurgical Generator

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K210488

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GEX 2021-10-25

Laser Treatment System, Model: Hera, Armo

Applicant Canadian Pioneer Medical Technology Corporation

K-Number K212793

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QKB 2021-10-25

Advanced Algorithms for Treatment Management Applications (AATMA)

Applicant Elekta Solutions AB

K-Number K212218

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LZA 2021-10-25

Best Glove-Nitrile Powder Free Examination Glove

Applicant Bestsafe Glove Co., Ltd.

K-Number K210249

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GEI 2021-10-25

Titan Manufacturing Bipolar Forceps

Applicant Titan Manufacturing, Inc.

K-Number K213386

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GAT 2021-10-25

Arthrex LoopLoc Knotless Suture

Applicant Arthrex, Inc.

K-Number K212146

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