10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MICRO-BOND HI-LIFE PROCELAIN & VIVERE
FDA 510(k)
FDA Class 2
·Dental
ACUMED
FDA UDI
Acumed LLC·10806378094934·1.1mm Non-threaded Guide Wire, 150mm
BLACKSTONE PILLAR XL PEEK SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
HORIZONS ERCP CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIFLUX 160NRD DIALYZER FINISHED ASSY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·March 24, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 6, 2007
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024