10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ToxiSeal Vial Adaptor
FDA 510(k)
FDA Class 2
·General Hospital
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 21, 2023
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
FDA 510(k)
FDA Class 2
·Orthopedic
PIONEER U121 SERIES CPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
CONSERVE(R) SUPER FINISH FEMORAL
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KXA·November 10, 2014
OVATIO CRT
FDA Adverse Event
Injury
·SORIN CRM S.A.S.·Product code MRM·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
ARCOS 17X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
ARCOS CON SZ C STD 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020