9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867234154·Submuscular Tissue Elevator, Dist Tibia
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STERILE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·May 20, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·December 31, 2012
UMBILICAL CORD CLAM, NS
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES·Product code FOD·May 5, 2015
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