BEUDAMED
    7 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

    FDA Recall
    Open, Classified ·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·November 20, 2023

    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

    FDA Recall
    Open, Classified ·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025

    Nussloch GmbH ASP6025 Tissue Processor

    FDA Recall
    Open, Classified ·Leica Microsystems, Inc.·Product code IEO·June 19, 2017

    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

    FDA Recall
    Open, Classified ·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·April 10, 2024

    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code OOE·October 21, 2021

    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code LZS·October 21, 2021

    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

    FDA Recall
    Open, Classified ·AMO Puerto Rico Manufacturing, Inc. Rd #·Product code HQL·February 19, 2026