17 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HV Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076173·Kirschner Blade 78 x 65mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076142·Kirschner hook-on retractors
40 x 5...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076197·retractor hook-on 80 x 90 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076210·retractor hook-on 98 x 50 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076180·frame hook 78 x 65 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076166·Kirschner frame hook
60 x 8...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076227·retractor hook-on 105x 35 mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076203·Kirschner blades
80 x 90mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076159·Kirschner hook-on retractors
50 x 6...
ENDOSKELETON TC
FDA 510(k)
FDA Class 2
·Orthopedic
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
BD PEGASUS YEL 24GAX0.75IN PRN-QSYTEY NOPVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 21, 2023
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