BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Avex CX2

    FDA 510(k)
    FDA Class 2 ·Dental

    Reamer Handle Shaft Grip Large

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215095970·

    EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BRECOMP

    FDA 510(k)
    FDA Class 2 ·Dental

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LWP·June 8, 2013

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 7, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019