BEUDAMED
    39 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    One Step K in vitro diagnostic test REF: 81A4

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step 10A in vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    One Step P in vitro diagnostic test REF: 8194

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

    FDA Enforcement
    Class II ·Terminated·Zavation·June 9, 2021

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Enforcement
    Class II ·Terminated·Sorin CRM SAS·August 22, 2018

    BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024