BEUDAMED
    22 results · 22ms · 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 ×

    Keeler Slit Lamp

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837087388·

    MICROSCAN MICROSTEP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRANSTEK GLASS BODY FAT ANALYZER

    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

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011

    ATRIUM OASIS CHEST DRAIN

    FDA Adverse Event
    Other ·J. REDMOND HANRAHAN GROUP, INC.·Product code KDQ·July 1, 2008

    ROI-C IMPLANT, UNKNOWN SIZE

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

    SPACER, UNKNOWN SIZE

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

    GLENOID, PE WITH PEG, MEDIUM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KWS·February 16, 2016

    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

    Precise Digital Accelerator Delivery of radiation to defined target volumes

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

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·October 3, 2018

    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

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014