19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSS-BODIES PROXIMAL TIBIAL SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801419·Adson Tissue Forceps - 1x2 Teeth, Fenestrated, ...
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POLYROX 45 JBP
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO.·Product code DTB·July 17, 2006
POLYROX 53/15 BP
FDA Adverse Event
Other
·BIOTRONIK GMBH AND CO.·Product code DTB·July 17, 2006
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013
ST JOSEPHS PHOENIX, AZ 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code DWF·July 31, 2009
RU NOVOSIBRIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·October 16, 2013
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
STRYKER, CUB
FDA Adverse Event
Injury
·UNK·Product code FMS·April 9, 2013
OLYMPUS
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·June 3, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
CP87641 GB SOUTHAMPTON
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·March 22, 2010
D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017
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