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

LZA 2021-07-21

Nitrile Patient Examination Glove

Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd.

K-Number K210686

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NKB 2021-07-21

CD Horizon Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211958

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OTN 2021-07-21

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Applicant Boston Scientific Corporation

K-Number K211223

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QJF 2021-07-21

MolecuLightDX

Applicant MolecuLight, Inc.

K-Number K211901

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OLP 2021-07-21

Aduro light therapy Handheld

Applicant Shenzhen Kaiyan Medical CO , Ltd.

K-Number K203271

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FYA 2021-07-21

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

Applicant O&M Halyard, Inc.

K-Number K210688

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FXX 2021-07-21

Surgical face mask (Model: Flat Ear Loop/CN102)

Applicant Crown Name Disposable Hygiene Products Fty., Ltd.

K-Number K203534

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QIH 2021-07-20

Change Healthcare Anatomical AI

Applicant Change Healthcare Canada Company

K-Number K210719

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LIP 2021-07-20

Elecsys Syphilis

Applicant Roche Diagnostics

K-Number K211302

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LLZ 2021-07-20

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

Applicant Zirkonzahn Srl

K-Number K203765

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IYN 2021-07-20

ACUSON Sequoia Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211859

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LZA 2021-07-20

Disposable Nitrile Medical Examination Glove

Applicant Jiangsu Cureguard Glove Co., Ltd.

K-Number K210684

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