13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Suture Wires and Wire Loops
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131283894·RIA2, MINIBTE 312 WL 85 TC
ENDOSKELETON TC
FDA 510(k)
FDA Class 2
·Orthopedic
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
FDA 510(k)
FDA Class 2
·General Hospital
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·May 29, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013
PRESERVATION UNI FEM CEM SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code HRY·June 29, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·September 2, 2008
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021
DIDECO EOS ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021
SORIN LIFEKIT D905 EOS ECMO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022
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