12 results · 11ms · Sources: EU EUDAMED, US FDA

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ClubMax Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

Logolas Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

Burstberry Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

Atom Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

Spectrum Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code BRX·July 10, 2019

Maxim Laser Projection Series

FDA Recall
Open, Classified ·Gk Photonics Inc·Product code REA·July 10, 2019

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