10 results
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17ms
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Sources: EU EUDAMED, US FDA
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756998369·U BAR DRAPE PACK
WAKO IMMUNOASSAY CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLEARCANVAS RIS / PACS
FDA 510(k)
FDA Class 2
·Radiology
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·November 23, 2010
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
EXTERNAL NEUROSTIMULATOR, UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 2, 2014
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems, Inc.·December 3, 2014
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
FDA Recall
Terminated
·Philips Medical Systems, Inc.·Product code FMP·October 10, 2014
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
FDA Enforcement
Class I
·Terminated·Childrens Medical Ventures·August 27, 2014