137 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Multitom RAX with software version VF10
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
FDA Recall
Terminated
·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009
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
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
FDA Recall
Terminated
·GVI Technology Partners·Product code IYX·January 16, 2004
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 Recall
Terminated
·Gsi Group Inc·Product code DSF·December 2, 2015
Multitom RAX with software version VF10
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Recall
Terminated
·Pentax Medical Company·Product code KOG·July 17, 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
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Recall
Terminated
·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014
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 Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·June 30, 2015
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
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
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 Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
FDA Enforcement
Class I
·Terminated·Pentax Medical Company·November 6, 2013