8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alteon Acetabular Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
ZenFlex
FDA UDI
Kerr Corporation·00195062029998·Rotary Files
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
FDA 510(k)
FDA Class 2
·Physical Medicine
GOLIFE NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 28, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 17, 2014
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019