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

    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 8, 2023

    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

    FDA Enforcement
    Class II ·Terminated·Cook Vascular Inc.·April 4, 2018

    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent, Inc.·August 5, 2015

    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

    FDA Enforcement
    Class II ·Ongoing·Qualigen Inc·October 16, 2024

    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

    FDA Enforcement
    Class II ·Terminated·Qualigen Inc·April 15, 2020

    ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·July 10, 2024

    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

    FDA Enforcement
    Class II ·Terminated·Qualigen Inc·September 13, 2017

    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·March 13, 2024

    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024