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

JOW 2021-11-18

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

Applicant Jiangsu Synecoun Medical Technology Co., Ltd.

K-Number K211937

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NUC 2021-11-18

Medley

Applicant Good Clean Love, Inc.

K-Number K212000

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NVK 2021-11-18

Gemini 2 810+980 Soft Tissue Laser

Applicant Azena Medical, LLC

K-Number K210350

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ESW 2021-11-18

HANAROSTENT Esophagus Asymmetric (CCC)

Applicant M.I.Tech Co., Ltd.

K-Number K213251

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NHA 2021-11-18

FAICO Dental Implant System and CAD/CAM Abutments

Applicant Faico Medical, LLC

K-Number K211871

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NUC 2021-11-18

Water-soluble Personal Lubricant

Applicant Foshan Pingchuang Medical Technology Co., Ltd.

K-Number K212104

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FYC 2021-11-17

Protect X Level 3 Isolation Gown

Applicant Azac Group

K-Number K211538

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MMK 2021-11-17

Promisemed Sharps container

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K211890

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PHX 2021-11-17

Arthrex Modular Glenoid System-Titanium Glenosphere

Applicant Arthrex, Inc.

K-Number K212415

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LNH 2021-11-17

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Applicant Hyperfine, Inc.

K-Number K212456

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QDQ 2021-11-17

Lunit INSIGHT MMG

Applicant Lunit, Inc.

K-Number K211678

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FXX 2021-11-17

Disposable Surgical Mask

Applicant Suzhou Letian Protective Products Co., Ltd.

K-Number K210042

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