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

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VariLymph 12 pro

FDA 510(k)
FDA Class 2 ·Cardiovascular

AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120

FDA 510(k)
FDA Class 2 ·Cardiovascular

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

FDA 510(k)
FDA Class 2 ·Radiology

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

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2008

EVIA DR-T

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code DXY·June 27, 2013

INTEGRIS ALLURA 9 (BIPLANE)

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code IZI·July 13, 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

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

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 24, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 7, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·May 18, 2023