7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
FDA 510(k)
FDA Class 2
·Orthopedic
AOI CRANIAL HELMET
FDA 510(k)
FDA Class 2
·Neurology
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
COVIDIEN LP·Product code GEI·October 6, 2014
ILS 29MM, CURVED
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 3, 2013
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·June 29, 2011
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018