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

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    MODIFICATION TO SPARC SLING SYSTEM

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

    KneeAlign 2

    FDA UDI
    Orthalign, Inc.·00858704006404·KneeAlign 2 Inner Tray

    RTE SNAPCONE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

    KRONNER LOW PROFILE SCOPE HOLDER

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

    HARDYDISK NETILMICIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REAR TIP EXTENDER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

    RTE SNAPCONE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

    PINNACLE ACETABULAR CUP SYSTEM, SZ 52MM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON·Product code KWA·March 18, 2013

    TRIATHLON-PS TIBIAL INSERT #7 - 13MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·March 7, 2011

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·March 27, 2008

    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·March 30, 2016

    AGILIS NXT INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·November 28, 2022

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014