8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DSL I-PTH (DSL #8000)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
INTER-PAL C-19 AND INTER-PAL C-38
FDA 510(k)
FDA Class 2
·Radiology
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 20, 2014
PRODISC-L SUP-PL SIZ L 6°
FDA Adverse Event
Injury
·SYNTHES·Product code MJO·January 4, 2013
ISOFLEX LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
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