BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    MRI PATIENT MONITORING SYSTEM TESLA M3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011163·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 32

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043779·2.0mm Short 4 Hole Locking Plate, 2.0mm thick

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023780·B-P HIP FEMORAL HEAD W/ULTRACOAT - 32 MM + 20 MM

    MAESTRO TOTAL WRIST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FOLYSIL CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·July 16, 2020

    FOLYSIL CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·July 16, 2020

    APHIS PLATEAU RADIAL T1

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWJ·May 19, 2017

    IMP,TSV,4.1MM,DUAL SEL,HA

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    AU2700 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMAK.K.·Product code JGS·June 28, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·August 31, 2022