BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517568571·CoRoent Ant TLIF Ti, 10x10x34mm 8°

    REYNOLDS TENOTOMY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054837·REYNOLDS TENOTOMY SCISSORS CURVED BLADES POWER ...

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828171458·GEN4 DIGITAL

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

    Sonoma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981050887·Sonoma Anterior Cervical Plate 3 Level Plate, 48mm

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981057169·Plate - 3 Level - 48 mm

    ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    COLORADO MICRODISSECTION NEEDLE

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

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 30, 2021

    STAT PROFILE PHOX PLUS ANALYZER

    FDA Adverse Event
    Death ·NOVA BIOMEDICAL CORP.·Product code JGS·November 14, 2003

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO45CT

    FDA Adverse Event
    Injury ·ONTEX HYGIENEARTIKEL GMBH·Product code HEB·August 5, 2021

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·October 24, 2014

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·August 11, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code IOR·July 1, 2013

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014