BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    EFAI NeuroSuite CT ICH Assessment System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Proxis™ Ureteral Access Sheath

    FDA UDI
    C. R. Bard, Inc.·00801741101670·Proxis™ Ureteral Access Sheath

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688047765·

    ihcDirect® Podoplanin Ab

    FDA UDI
    NOVODIAX, INC.·00850000596337·Clone C125

    ihcDirect® Podoplanin Ab

    FDA UDI
    NOVODIAX, INC.·00850000596320·Clone C125

    ihcDirect® Podoplanin Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934413·Clone C125

    ihcDirect® Podoplanin Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934420·Clone C125

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197122511·Capener Osteotome curved...

    0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2021

    ARCHON ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oral/Enteral Syringe with ENFit connector

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

    MEDLINE

    FDA Adverse Event
    Malfunction ·SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD·Product code FMI·June 8, 2024

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 21, 2014

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 30, 2008

    LINOX SD 75/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·July 19, 2011

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2013

    JUVEDERM ULTRA XC 1 ML ROW

    FDA Adverse Event
    Injury ·ALLERGAN (PRINGY)·Product code LMH·September 23, 2015

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 21, 2021

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020