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

GAT 2022-09-09

Arthrex SutureTape

Applicant Arthrex, Inc.

K-Number K221354

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MLR 2022-09-09

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

Applicant Steris

K-Number K222093

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FRG 2022-09-09

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

Applicant Steris

K-Number K222440

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HSB 2022-09-09

AUTOBAHN(R) EVO Femoral Nails

Applicant Globus Medical, Inc.

K-Number K220659

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GEI 2022-09-09

Ellusa Reusable Bipolar Cable

Applicant Ellusa, LLC

K-Number K222429

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ELW 2022-09-09

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)

Applicant Prevest Denpro Limited

K-Number K213244

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NKG 2022-09-09

NuVasive Reline Cervical System

Applicant Nu Vasive, Incorporated

K-Number K221388

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GEX 2022-09-08

Dynamis Pro Family

Applicant Fotona D.O.O.

K-Number K213267

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ODC 2022-09-08

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K-Number K221331

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ELC 2022-09-08

Ultrasonic Endo Activation Device (Model:Actor I pro)

Applicant Changzhou Bomedent Medical Technology Co.,Ltd

K-Number K213947

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LRK 2022-09-08

Soundly Anti Snoring Device

Applicant Greystone Ip, Ltd.

K-Number K220330

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NWB 2022-09-08

HD-550 Video Endoscope System

Applicant Sonoscape Medical Corp.

K-Number K222020

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