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

KRA 2023-05-02

TriSalus TriNav® LV Infusion System

Applicant Trisalus Life Sciences

K-Number K230957

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DQK 2023-05-02

AcQMap® High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K230606

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KGN 2023-05-02

FortiShield (Biosynthetic Wound Matrix)

Applicant Organogenesis, Inc.

K-Number K212579

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LLZ 2023-05-01

CarnaLife Holo

Applicant Medapp S.A.

K-Number K221870

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OIV 2023-05-01

Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy

Applicant Worldwork S.R.L

K-Number K223182

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FRF 2023-05-01

RIA Safeguard

Applicant Ria Tech Co., Ltd.

K-Number K222416

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QRC 2023-05-01

vPATCH

Applicant Virility Medical , Ltd.

K-Number K223595

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PGY 2023-05-01

CP620G LCD monitor, CP620 LCD monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K230643

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HWC 2023-04-28

Hand Trauma Threaded Nail System

Applicant Skeletal Dynamics, Inc.

K-Number K230908

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GCJ 2023-04-28

Bladeless Trocar – Artemis Lap Cannula

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K230058

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NHA 2023-04-28

Titanium Abutment Blank Nobel Biocare N1 TCC

Applicant Nobel Biocare AB

K-Number K223677

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IZF 2023-04-28

Nanox.ARC

Applicant Nano-X Imaging , Ltd.

K-Number K222934

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