231 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.
FDA Recall
Terminated
·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·March 17, 2010
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·August 23, 2023
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·July 9, 2024
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 Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·July 9, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·July 9, 2024
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·August 23, 2023
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·July 9, 2024
OMTech Desktop Laser Engraver
FDA Recall
Open, Classified
·Rygel Advanced Machines d/b/a Omtech Laser·Product code RIM·June 7, 2024
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Recall
Open, Classified
·DICOM Grid, Inc. d/b/a Ambra Health·Product code LLZ·June 23, 2022
OMTech Desktop Laser Engraver
FDA Enforcement
Class II
·Ongoing·Rygel Advanced Machines d/b/a Omtech Laser·June 19, 2024
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022