BEUDAMED
    181 results · 14ms · Sources: EU EUDAMED, US FDA

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    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

    FDA Recall
    Open, Classified ·Product code KWP·September 16, 2019

    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

    FDA Recall
    Open, Classified ·Product code KWP·September 16, 2019

    I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

    FDA Recall
    Open, Classified ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HWC·January 26, 2024

    I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

    FDA Recall
    Open, Classified ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HWC·January 26, 2024

    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

    FDA Recall
    Open, Classified ·Blue Belt Technologies, Inc·Product code OLO·September 7, 2023

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·October 1, 2025

    Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·October 1, 2025

    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

    FDA Recall
    Open, Classified ·Product code LXH·February 4, 2019

    Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)

    FDA Recall
    Open, Classified ·CooperVision, Inc.·Product code LPM·January 26, 2023

    Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

    FDA Recall
    Open, Classified ·CooperVision, Inc.·Product code LPM·January 26, 2023

    Oculus Pentacam AXL Wave, Ref 70020, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    Oculus Pentacam AXL , Ref 70100, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    Oculus Myopia Master , Ref 68100, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    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

    BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.

    FDA Recall
    Open, Classified ·CooperVision, Inc.·Product code LPM·August 29, 2024

    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