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

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    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707531·Cottle Thumb Hook Retractor, 1-1/2" (3.8cm) wor...

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133944·LATERAL,RAKE CURETTE WELDMENT,BENT

    AVL HINGE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECTRONIC SPHYGMOMANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

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

    TRINITY

    FDA Adverse Event
    Injury ·CORIN LTD·Product code LZO·December 13, 2022

    ACETABULAR GUIDE

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD.·Product code PBF·December 13, 2022

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    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