10 results
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19ms
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Sources: EU EUDAMED, US FDA
CARDIOPLEGIA DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750000791·VITROS Immunodiagnostic Products CK-MB Range Ve...
ACUMED
FDA UDI
Acumed LLC·10806378041679·Trial Lkg RH Tray Insert Lid
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DIAMONDBACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·March 30, 2026
BIODESIGN 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH INC·Product code PAG·April 3, 2014
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·October 22, 2012
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021