BEUDAMED
    33 results · 23ms · Sources: EU EUDAMED, US FDA

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    Dynamic Code AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device

    Dymond tube

    Device
    EU IVDR · Eu Ivd Class A ·Dynamic Code AB·On the market

    Dymond Tube

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Dynamic Code AB·1 device

    Code of Practice AB

    Authorized representative
    🇸🇪 Sweden·8 Manufacturers

    Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.

    FDA Enforcement
    Class II ·Ongoing·ORTOMA AB·October 1, 2025

    LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

    FDA Enforcement
    Class II ·Ongoing·Jolife AB·May 20, 2026

    Lifco Dental AB

    Importer
    🇸🇪 Sweden·1 Manufacturer

    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

    FDA Enforcement
    Class II ·Ongoing·Jolife AB·July 2, 2025

    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

    FDA Enforcement
    Class II ·Ongoing·Nobel Biocare·February 12, 2025

    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

    FDA Enforcement
    Class II ·Ongoing·Hermes Medical Solutions AB·December 18, 2024

    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

    FDA Enforcement
    Class II ·Ongoing·ELEKTA SOLUTIONS AB·November 26, 2025

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·September 4, 2019

    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

    FDA Enforcement
    Class II ·Ongoing·Nobel Biocare·August 31, 2022

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    XVIVO Organ Chamber REF 19020

    FDA Enforcement
    Class II ·Terminated·XVIVO PERFUSION AB·June 8, 2022

    Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Sonesta Medical AB·November 19, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026