64 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·February 2, 2015
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Recall
Terminated
·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·September 25, 2014
Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.
FDA Recall
Terminated
·Stryker Spine·Product code LXH·December 7, 2010
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
FDA Recall
Terminated
·FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands·Product code DXN·July 6, 2012