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

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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FOZ 2021-10-25

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K213085

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FXX 2021-10-25

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

Applicant Jiangmen Ningrui Medical Supplies Co., Ltd.

K-Number K212293

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FXX 2021-10-24

Surgical Face Mask

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K212368

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FXX 2021-10-24

Disposable Medical Surgical Mask

Applicant Weihai Dishang Medical Technology Co., Ltd.

K-Number K210348

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