8 results
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7ms
·
Sources: EU EUDAMED, US FDA
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
FDA Enforcement
Class II
·Ongoing·Abbott Vascular·April 20, 2022
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021