11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SERVICE, CCU, HIGH DEF, 560P, 2NDGEN
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
UNKNOWN DEPUY SROM FEMORAL HIP STEM
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code JDI·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
HUMAPEN EROG, BURGUNDY/CLEAR
FDA Adverse Event
Malfunction
·ELI LILLY AND CO.·Product code FMF·June 30, 2008
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022