17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MITEK SUTURE RETROGRADER
FDA 510(k)
FDA Class 1
·Orthopedic
artegral
FDA UDI
Merz Dental GmbH·D7091970360·anteriors; shade C4; mould BIS
F.A.S.T. 1
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·May 30, 2006
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
FDA 510(k)
FDA Unclassified
·Unknown
NAVIO
FDA 510(k)
FDA Class 2
·Neurology
FASTI INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·June 29, 2017
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Malfunction
·DEXCOM INC.·Product code MDS·February 20, 2013
GRAFTON PLUS DBM PASTE
FDA Adverse Event
Injury
·OSTEOTECH, INC.·Product code MBP·January 14, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·July 31, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022