BEUDAMED
    1,354 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    HENRY SCHEIN, OMFS, Item No.570-2779,

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022

    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

    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    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

    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

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 17, 2012

    NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile. (5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (9) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038301, UPN H965700383011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (10) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038303, UPN H96570038301, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (11) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039202, UPN H965700392021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (12) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039301, UPN H965700393011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; and (13) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039303, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·October 6, 2021