BEUDAMED
    19 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 ×

    PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner

    FDA 510(k)
    FDA Class 2 ·Dental

    AGXO

    FDA UDI
    Oticon A/S·05707131283771·H100V2, BTE 13 WL 100 CBE AGXO

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240711·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036077624·

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099379·Procera Implant Bridge Ti Abut Level 9 unit

    OLYMPUS CF TYPE Y0023-L, Y0023I

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OSCAR, MODEL OE3000DB

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 29, 2019

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 8, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·October 13, 2022

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014