9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
MICROFLUOR B PLATE & MICRO FLUOR W PLATE
FDA 510(k)
FDA Class 1
·Microbiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229600·Tranquil-L ALIF Trial 12x32x25, 12 deg
GE QUASAR NUCLEAR MEDICINE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
FDA 510(k)
FDA Class 2
·Cardiovascular
MAESTRO MEDIUM FIXED DURAGUARD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBB·May 21, 2014
SUPER MULTIVAC 50 ICW
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·October 23, 2012
SODASORB
FDA Adverse Event
Malfunction
·W.R. GRACE AND COMPANY·Product code CBL·August 12, 2010
VANGUARD XP INTERLOK TIBIAL TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·April 8, 2019
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