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

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BYRNE EXPULSIVE LENS

FDA 510(k)
FDA Class 1 ·Ophthalmic

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

FDA 510(k)
FDA Class 2 ·Cardiovascular

SINGLE USE ORAL MASK, MODEL HC455A

FDA 510(k)
FDA Class 2 ·Anesthesiology

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

UNKNOWN DEPUY SROM STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·December 9, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014

SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·December 3, 2014

NAVIGATION STEALTHSTATION TOOL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·September 27, 2018

UNKNOWN

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code KGE·April 4, 2017

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 29, 2025

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·May 16, 2024

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 21, 2021

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 6, 2025

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·September 15, 2023

GUIDE WIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 25, 2025

RADIFOCUS GUIDEWIRE

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DQX·December 5, 2023

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 3, 2018

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 23, 2026

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 11, 2026