17 results · 32ms · Sources: EU EUDAMED, US FDA

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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