BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    ISOROD PD-103 IMPLANT, MODEL ATI-PD-103

    FDA 510(k)
    FDA Class 2 ·Radiology

    WMT ULTRA-FIT MODULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFIED SINGLE AXLE TOTAL ELBOW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 26, 2013

    TRIATHLON-CR FEMORAL COMPONENT CEMENTED #7 LEFT

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

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·March 28, 2008

    T-PAL SPACER APPLICATOR KNOB

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·April 27, 2015

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025

    INSPIRE 7F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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