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

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    MODEL 9000 PEDIATRIC WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102459·Astra®-compatible Aqua 3.5/4.0mm Esthetic Abutm...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964016965·The ENDO CARRY-ON Procedure Kit contains all of...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002170·artVeneer life upper posteriors, XL, BL2

    Lattus

    FDA UDI
    Seaspine Orthopedics Corporation·10889981308636·EMG Center Blade - 170mm

    SURGITEK MAMMARY PROSTHESIS

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·May 23, 1994

    SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000

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

    GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

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

    BD DISCARDIT SYRINGE S2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 22, 2024

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011

    *

    FDA Adverse Event
    Malfunction ·ALLERGAN, INC.·Product code LCJ·January 28, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·August 11, 2021

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022