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

HSB 2022-11-15

Gamma4 System

Applicant Stryker GmbH

K-Number K222309

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CAC 2022-11-15

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

Applicant Haemonetics Corporation

K-Number K221722

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GEX 2022-11-15

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

Applicant Canadian Pioneer Medical Technology Corporation (Cpmt Laser)

K-Number K222915

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NKB 2022-11-15

Dyflex-II

Applicant Taeyeon Medical Co., Ltd.

K-Number K212700

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DPS 2022-11-15

Cardio10

Applicant Bionet Co., Ltd.

K-Number K220535

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HBE 2022-11-15

2.1 x 255mm Drill, 22mm Stop

Applicant Biomet Microfixation

K-Number K223199

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HRS 2022-11-15

ALPHALOK Plating System

Applicant Vilex, LLC

K-Number K221558

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HWC 2022-11-15

Treace Medical Concepts (TMC) Hammertoe Fixation System

Applicant Treace Medical Concepts, Inc.

K-Number K222564

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OVE 2022-11-15

Omnia Medical TiBrid-SC

Applicant Omnia Medical, LLC

K-Number K212612

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NUH 2022-11-15

Everyway Analog OTC TENS

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K222488

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NUC 2022-11-15

Bloomi Delight Oil-Based Personal Lubricant

Applicant The Bloomi Inc..

K-Number K222175

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OUO 2022-11-14

uPMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K222540

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