7 results
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47ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sea-Band
FDA UDI
SEA-BAND LIMITED·00008727000013·The Sea-Band is an elasticated band that can be...
Sea-Band
FDA UDI
SEA-BAND LIMITED·00008727000372·The Sea-Band is an elasticated band that can be...
Sea-Band
FDA UDI
SEA-BAND LIMITED·00008727001027·The XL Sea-Band is an elasticated band that can...
Sea-Band
FDA UDI
SEA-BAND LIMITED·00008727000020·The Sea-Band is an elasticated band that can be...
THERMACARE HEATWRAP
FDA Adverse Event
Malfunction
·PFIZER CONSUMER HEALTH CARE·Product code IMD·October 31, 2019
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code ILI·October 31, 2016