22 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OMNI 3 OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704042·Iris Tissue Forceps 4" (10cm), straight, 1x2 te...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450239650·
INTROCAN SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 1
·Dental
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 20, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 10, 2011
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·August 15, 2008
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·October 2, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016