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

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    2.4MM CORTEX SCREW, SELF-TAPPING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102688·Astra®-compatible Lilac 4.5/5.0mm Esthetic Abut...

    Preat

    FDA UDI
    Preat Corporation·00842092175491·Astra®-compatible Aqua 4.5/5.0mm 15° Esthetic A...

    HARDYDISK, SULFA/TRIMETH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAMARCO SPIDER PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 13, 2013

    ASR UNI FEMORAL IMPL SIZE 43

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

    REPLICA LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDG·February 20, 2008

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025

    2.0X9MM FOSSA X-DR SCRW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·July 30, 2013

    TMJ MED RTFOSSA COMP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·July 26, 2013

    EB217, VOYANT MARYLAND FUSION 23CM, 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GEI·August 23, 2023

    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

    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