BEUDAMED
    566 results · 7ms · Sources: EU EUDAMED, US FDA

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

    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    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

    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·March 4, 2026

    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·June 9, 2021

    OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

    FDA Enforcement
    Class II ·Ongoing·Haag-Streit USA Inc·January 19, 2022

    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

    FDA Enforcement
    Class II ·Ongoing·Haag-Streit USA Inc·January 19, 2022

    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

    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).

    FDA Enforcement
    Class II ·Ongoing·Fujifilm Medical Systems U.S.A., Inc.·April 14, 2021

    Paradigm REF: MMT-712 and MMT-715

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·March 12, 2025

    NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 5, 2023

    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 5, 2023

    MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·March 12, 2025

    MiniMed insulin pump, REF: 620G (MMT-1750)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·March 12, 2025

    MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·March 12, 2025

    MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·March 12, 2025