BEUDAMED
    13 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

    FDA Enforcement
    Class II ·Ongoing·Zimmer Surgical Inc·February 21, 2024

    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 5. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 6. IV START KIT, Medline Kit SKU DYNDV2520; 7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 9. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12; 5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775; 7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12; 8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 9. IV START KIT, Medline Kit SKU IV8675; 10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940; 12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B; 4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B; 5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A; 6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A; 7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810; 8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100; 9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340; 10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660; 11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026