214 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 14, 2018
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017
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
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 15, 2015
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
Sterile, Drape, Headset, Lower, Part Number 888944-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Sterile, Drape, Headset, Upper, Part Number 888945-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
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
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016