11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Actreen Mini Intermittent Urinary Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASAHI TORNUS SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TSRH(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·September 14, 2017
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023