BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    Thommen Milling Abutment for CAD/CAM

    FDA 510(k)
    FDA Class 2 ·Dental

    SPI VARIO ANGLED ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300

    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

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·July 7, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    TERUMO ENDO SHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DYB·September 8, 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

    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

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014