10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HI-RIDER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
BVN
FDA 510(k)
FDA Class 1
·Physical Medicine
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
FDA 510(k)
FDA Class 2
·Neurology
UNO INSET I 60/6 GREY TCAP 10PK INT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
UNO INSET I 60/6 GREY TCAP 10PK INT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 18, 2024
UNO INSET I 60/6 GREY TCAP 10PK INT
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 18, 2024
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 24, 2014
V40 COCR LFIT HEAD 36MM/+10
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·November 1, 2010
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·December 26, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012