18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RM3 RENAL PRESERVATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV
TABLETOP SHIELD
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175002247·Shield, Tabletop, Standard, .5" Lead
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356894·
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009
VERTEX RECONSTRUCTION SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
MUSTANG¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·April 9, 2013
NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code MBH·February 15, 2011
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025