15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BOTTLE, BLOOD CULTURE, SCHAEDLER
FDA 510(k)
FDA Class 1
·Microbiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110621·COAXIAL VISCOELASTIC ASPIRAT-IRRIGAT TIP
BI IMAGE-X EVOLUTION
FDA 510(k)
FDA Class 2
·Dental
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE CHOCOLATE II AGAR 100 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·November 1, 2021
PLATE CHOCOLATE II AGAR 100 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·August 11, 2021
PLATE CHOCOLATE II AGAR 100 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·August 25, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·September 26, 2012
SENSATION 7FR. 40CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·July 14, 2010
PLATE CHOCOLATE II AGAR 100 EA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 27, 2022
PLATE CHOCOLATE II AGAR 100 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·August 17, 2021
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
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