BEUDAMED
    248 results · 41ms · 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 ×

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code MLZ·August 5, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code MPA·August 5, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code HQE·August 5, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code HQC·August 5, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code NGY·August 5, 2025

    See Luer Cap Set, MPC-130, set, administration, intravascular

    FDA Recall
    Open, Classified ·Molded Products Inc·Product code FPA·February 17, 2026

    Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

    FDA Recall
    Open, Classified ·Medical Action Industries, Inc.·Product code LRO·March 17, 2026

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·November 30, 2020

    ARTIS Pheno VE30A and VE40A, Model 10849000

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·March 12, 2026

    ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·March 10, 2026

    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·September 12, 2024

    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

    Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021

    Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021

    Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021

    Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code PZG·November 17, 2021

    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·May 3, 2022

    The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

    FDA Recall
    Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·February 23, 2024

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022