9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLUX SURGICAL HEADLIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704659293·Gibeck Humid Flo Passive Humidification Kit
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·04026704597352·Gibeck Humid Flo Passive Humidification Kit
ANGIOGRAPHY CUSTOM PACKS
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE SPO2 SENSOR M1134A
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 6, 2013
DYONICS STONECUTTER
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HRX·February 9, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·August 8, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020