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

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    Filters Classification: Class Ii ×

    Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System

    FDA Enforcement
    Class II ·Terminated·Biomet U.K., Ltd.·March 1, 2017

    Burlington Medical, Wrap Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·November 5, 2014

    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

    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    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

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Enforcement
    Class II ·Ongoing·Barco N.V.·February 14, 2024

    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

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

    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

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

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

    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Enforcement
    Class II ·Terminated·Biomet Microfixation, LLC·December 17, 2014

    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Enforcement
    Class II ·Terminated·Biomet Microfixation, LLC·December 17, 2014

    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint

    FDA Enforcement
    Class II ·Terminated·Biomet Microfixation, LLC·December 17, 2014

    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Enforcement
    Class II ·Terminated·Biomet Microfixation, LLC·December 17, 2014