9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
V2465P X-RAY IMAGE INTENSIFIER
FDA 510(k)
FDA Class 2
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756670012·LAP CHOLE TRAY
UNI-STICK PLASTIC LIGATURES
FDA 510(k)
FDA Class 1
·Dental
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
FDA 510(k)
FDA Class 2
·Orthopedic
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 20, 2014
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·December 31, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014