BEUDAMED
    30 results · 27ms · Sources: EU EUDAMED, US FDA

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    NEODENT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    First Choice Partial Ulnar Head Implant

    FDA UDI
    Smith & Nephew, Inc.·00885556826553·FIRST CHOICE HEAD 19.0-STEM 4.5

    RIGID GAS PERMEABLE CONTACT LENS SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 6, 2013

    DURA STAR RX PTCA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LOX·August 6, 2008

    NEPTUNE 2 DOCKING STATION (120V)

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·May 18, 2011

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·November 16, 2023

    BD SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 20, 2024

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024