BEUDAMED
    15 results · 23ms · 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.

    RA-308 Excimer Laser System, Excimer Laser Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131318787·OPN 3, MRITE 312 2.4G NFM PB C092

    VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CLEAR+BRILLIANT LASER SYSTEM

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

    CODEMASTER XL+

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·May 28, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 9, 2008

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025

    GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019

    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022