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

IYN 2023-09-26

ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232617

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QRA 2023-09-25

Smileyscope System (Therapy Mode)

Applicant Smileyscope Holding, Inc.

K-Number K230825

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FMF 2023-09-25

BD Texium Needle-Free Syringe

Applicant Care Fusion

K-Number K231888

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KTI 2023-09-25

EndoCore

Applicant Praxis Medical, LLC

K-Number K230778

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OTM 2023-09-25

Virtue Male Sling System with Alexis Wound Retractor Convenience Kit

Applicant Coloplast

K-Number K231891

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HRS 2023-09-25

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

Applicant Exactech, Inc.

K-Number K223933

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QUH 2023-09-25

Self-Fitting hearing aids

Applicant Huizhou Jinghao Medical Technology Co., Ltd.

K-Number K221052

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OUR 2023-09-25

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K-Number K230857

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OVE 2023-09-25

Cervical Spine Truss System (CSTS)

Applicant 4Web Medical, Inc.

K-Number K231739

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QKB 2023-09-25

EFAI RTSUITE CT HCAP-Segmentation System

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K231928

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OHT 2023-09-25

PEACH 2, PEACH 2 Duo, PEACH 2 go

Applicant Foreo, Inc.

K-Number K231977

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OVD 2023-09-25

IdentiTi ALIF Interbody Systems

Applicant Alphatec Spine, Inc.

K-Number K232097

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