17 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Bite Away
FDA 510(k)
FDA Class 2
·Physical Medicine
INVADER FACTOR II
FDA 510(k)
FDA Class 2
·Hematology
LOGIQ E9
FDA 510(k)
FDA Class 2
·Radiology
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICK CREEK MANUFACTURING·Product code LKK·June 16, 2011
MULTI-LUMEN CVC KIT W/BLUE FLEXTIP CATHETER
FDA Adverse Event
Injury
·ARROW-HOWES, ARROW INTERNATIONAL·Product code DQO·September 12, 2008
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017