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

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    MR-III

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

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102640·Astra®-compatible Lilac 4.5/5.0mm X 4.5mm Titan...

    Procure

    FDA UDI
    Twin Med, LLC·10840330700228·HMEF Adult In-Line Maxi W/Sampling Port 350 - 1...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130070·Astra®-compatible Lilac 4.5/5.0 mm X 4.5 mm Eng...

    HMEF

    FDA UDI
    WESTMED, INC.·00709078014253·HMEF Adult In-Line Maxi W/Sampling Port 350 - 1...

    L720 EXAMINATION CHAIR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    ASR ACETABULAR CUPS 58

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

    PINN CAN BONE SCREW 6.5MMX40MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·February 20, 2008

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    PINNACLE 100 HA ACET CUP 48MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code LPH·October 18, 2023

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025

    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code IYN·January 13, 2020

    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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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