BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.

    FDA Enforcement
    Class II ·Ongoing·SunMed Holdings, LLC·November 29, 2023

    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·November 20, 2013

    VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

    FDA Enforcement
    Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·October 19, 2022

    MIM software; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·MIM Software Inc·March 12, 2025