29 results · 24ms · Sources: EU EUDAMED, US FDA

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Simplant Digital Guide

FDA 510(k)
FDA Class 1 ·Dental

Cardiovascular Procedure Kit

FDA UDI
Terumo Cardiovascular Systems Corporation·00699753530980·

PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

FDA 510(k)
FDA Class 2 ·Orthopedic

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·October 22, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 12, 2025

CONTOUR PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·June 27, 2013

AXIUM 3-D DETACHABLE COIL

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code HCG·October 7, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

CARDIOCHEK PLUS ANALYZERQ

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·August 18, 2022

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·July 28, 2023

CONTOUR PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·May 24, 2024

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 6, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 11, 2024

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·November 21, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 14, 2024