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

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    Biomet Microfixation RibFix Advantage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113738·CCC CYSTOTOME FORMED 25GA

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWC·February 27, 2017

    Symbia 6.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

    FDA 510(k)
    FDA Class 2 ·Dental

    RSP SHOULDER INSTRUMENT

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HTQ·October 17, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    MEGA NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 2, 2013

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 17, 2022

    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012