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

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    Steinmann Pins and Kirschner Wires

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857308022·Parallel Rasp Size: 18x45x13 mm

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·February 1, 2022

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    CD HORIZON

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·October 17, 2008

    BREEZE CEMENT

    FDA Adverse Event
    Injury ·PENTRON CLINICAL·Product code EMA·August 15, 2011

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 8, 2013

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    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