BEUDAMED
    21 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.
    Filters Regulation: Us FDA ×

    A7 Anesthesia System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NMI MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·October 6, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

    BIOPATCH 4151

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FRO·June 17, 2016

    BIOPATCH 4151

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FRO·June 16, 2016

    BIOPATCH 4151

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FRO·June 16, 2016

    SPACER, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    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