8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MUL-T-PAD
FDA 510(k)
FDA Class 1
·Physical Medicine
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ReNew V Handpiece Laparoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 11, 2014
3002 SECURE II MED-SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·September 19, 2012
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·July 12, 2010
Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025