12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dignity Dual Port
FDA 510(k)
FDA Class 2
·General Hospital
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532380·Crossbar Acetabular Reamer - 38mm
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
1.5T OPTIMA MR430S
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 24, 2026
BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 12, 2026
SYRINGE 20ML LL NS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 6, 2025
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, IRVINE·Product code OAD·May 27, 2011
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 5, 2008
BD SYRINGE 20ML LL NS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 9, 2026
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