10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ARTHREX IBALANCE TKA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131264831·RIA, KIT 312 WL OMNI R BE
CEROX
FDA 510(k)
FDA Class 2
·Cardiovascular
PLEURX PERITONEAL CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·October 1, 2014
XENFORM
FDA Adverse Event
Other
·TEI BIOSSCIENCES INC·Product code FTM·May 24, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 12, 2011
UNKNOWN
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 20, 2025
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023