14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GFS Ultimate
FDA 510(k)
FDA Class 2
·Orthopedic
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
COMPACT TOUCH STS
FDA 510(k)
FDA Class 2
·Radiology
FREESTYLE LIBRE 14 DAY
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 3, 2019
ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·June 14, 2007
8CM HEAVY DUTY MEDIUM ATTACH
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 11, 2013
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 7, 2011
STERLING OVER-THE-WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQY·September 16, 2008
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Death
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 23, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024