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