15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ClearEdge Balance System
FDA 510(k)
FDA Unclassified
·Unknown
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304673946·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304648029·
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
AVS TL PEEK SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
PARENCHYMAL PRESSIO CATHETER
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·September 18, 2018
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
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
M2A 38MM MODULAR HEAD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·July 8, 2011
VANGUARD ARCOM SERIES-A PATELLA
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·May 10, 2018
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023