Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

NUH 2022-12-21

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

Applicant Andon Health Co, Ltd.

K-Number K222867

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FYA 2022-12-21

Comfort Gown, Safewear Gown

Applicant Xuchang Zhengde Environstar Medical Products Co., Ltd.

K-Number K213893

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HRS 2022-12-21

TriMed Wrist Fixation System 3

Applicant TriMed, Inc.

K-Number K222637

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EOQ 2022-12-21

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

Applicant Pentax of America, Inc.

K-Number K213235

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HRX 2022-12-21

Pristine Arthroscopic Visualization System

Applicant Pristine Surgical

K-Number K223244

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EBG 2022-12-21

CURA-Temp

Applicant Mgnewton , Ltd.

K-Number K202965

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FRO 2022-12-21

ELECTROCYN soma

Applicant V3Bio Sdn. Bhd

K-Number K220286

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LOX 2022-12-21

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter

Applicant Sino Medical Sciences Technology, Inc.

K-Number K222538

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BTT 2022-12-21

inspired™ VHB20 Heated Humidifier

Applicant Vincent Healthcare Products Limited

K-Number K222351

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NBW 2022-12-21

GlucoSure ADVANCE Link Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K222234

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OVE 2022-12-20

AEON-C™ Stand Alone System

Applicant Dio Medical, Inc.

K-Number K223140

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QHE 2022-12-20

Smart SPACE Shoulder Planner and 3D Positioners

Applicant Lima Corporate S.P.A.

K-Number K222405

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