BEUDAMED
    12 results · 33ms · Sources: EU EUDAMED, US FDA

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    3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133920·LATERAL,CUP CURETTE WELDMENT,DOWN BEND

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707524·Gruber Columella Retractor with Weight

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197132435·DEFOURMENTEL Bone Rongeur, 3mm jaws 190mm,...

    ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOMARC FIDUCIAL MARKER

    FDA 510(k)
    FDA Class 2 ·Radiology

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025