BEUDAMED
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    BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code HMX·February 2, 2024

    BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code HMX·May 25, 2022

    Quick Release Gait Belt, 60

    FDA Recall
    Open, Classified ·Medline Industries Inc·Product code IKX·September 15, 2020

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Recall
    Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024

    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.

    FDA Recall
    Open, Classified ·Iantrek Inc.·Product code HMX·September 6, 2025

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    FDA Recall
    Open, Classified ·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·February 8, 2024

    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)

    FDA Recall
    Open, Classified ·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·June 7, 2023

    DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Recall
    Open, Classified ·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025

    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·March 29, 2024

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code LZD·December 6, 2022

    8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code PGW·April 4, 2024