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

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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DSH 2023-09-25

Holter ECG and ABP System

Applicant Edan Instruments, Inc.

K-Number K230184

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NBC 2023-09-24

ADVIA Centaur® NT-proBNPII (PBNPII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K220265

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DZE 2023-09-23

Osstem Implant System

Applicant Osstem Implant Co., Ltd.

K-Number K222778

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