11 results
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18ms
·
Sources: EU EUDAMED, US FDA
HEMASTAIN FIXATIVE
FDA 510(k)
FDA Class 1
·Hematology
Ceramill® Liquid
FDA UDI
Amann Girrbach AG·E4947604851·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110621·COAXIAL VISCOELASTIC ASPIRAT-IRRIGAT TIP
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
VERIFY VH2O2 Indicator Tape
FDA 510(k)
FDA Class 2
·General Hospital
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 26, 2012
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 15, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025