7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DASS PACK
FDA 510(k)
FDA Class 1
·Hematology
MEDCOMP SPLIT CATH II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MultiScan G-Arm System
FDA 510(k)
FDA Class 2
·Radiology
RENASYS EZ PLUS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW WOUND MANAGEMENT·Product code BTA·June 5, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 29, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·September 22, 2010
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020