7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NEW JERSEY FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BEDSIDE TINNITUS MASKER #1500
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 1, 2014
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 27, 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