14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111059261·SKLHN PLAST SCIS CVD 4 3/4"
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SECURIS SPINAL FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
FEMORAL NAIL, A/R T2 FEMUR ? 10X360MM
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 7, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 5, 2008
SENSITHERM PROBE
FDA Adverse Event
Injury
·FIAB S.P.A.·Product code FLL·July 10, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
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