27 results · 21ms · Sources: EU EUDAMED, US FDA

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MILLAR MIKRO-TIP DOPPLER CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209115990·KIT, ROO - CUSTOM

Cerdak Basic

FDA 510(k)
FDA Unclassified ·Unknown

MYSET PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 1, 2025

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 4, 2025

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 23, 2025

LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·April 2, 2014

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 30, 2012

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 22, 2010

COBAS C 303 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 12, 2025

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 12, 2025

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 14, 2021

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 14, 2022

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 20, 2022

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 31, 2024

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 8, 2025

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 11, 2022

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·September 28, 2023