11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DNAP Electrode
FDA 510(k)
FDA Class 2
·Neurology
BELMONT BUDDY FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
COROENT INTERLOCK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
BD CONNECTA¿
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·October 19, 2017
BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·September 27, 2017
APEX KNEE SYSTEM
FDA Adverse Event
Injury
·OMNLIFE SCIENCE, INC.·Product code JWH·June 5, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 27, 2011
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023