8 results
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5ms
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Sources: EU EUDAMED, US FDA
Multitom RAX with software version VF10
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 27, 2014
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·July 2, 2014
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 23, 2015
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Enforcement
Class II
·Terminated·Gsi Group Inc·March 2, 2016
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·December 23, 2015
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014