22 results
·
29ms
·
Sources: EU EUDAMED, US FDA
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189768·*USE K011231*LEVAMED ACTIVE ANKL SUP BL
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513279·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513316·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513262·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513286·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513293·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513309·
ILT DEFLECTING CATHETER, MODEL C114ND1
FDA 510(k)
FDA Class 2
·Cardiovascular
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 21, 2025
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 21, 2025
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013
STRATA 2, ADJUSTABLE VALVE, REGULAR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 3, 2011
INSYNC II MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·March 10, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 2, 2016
ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020
INDIGO SYSTEM ASPIRATION CATHETER 6
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 12, 2019
ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015