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

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    INVIGRA

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

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113805·PS-C Insert, Size 6 x 14mm

    Spine Innovation Interbody System

    FDA UDI
    SPINE INNOVATION, LLC·00817722020212·Expandable Implant 0° x 12mm W x 14mm H x 26mm L

    KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVENT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    GENTLECATH INTERMITTENT URINARY CATHETER 12CH

    FDA Adverse Event
    Other ·CONVATEC·Product code KNX·March 22, 2013

    COMPACT EXCHANGE DEVICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code KDJ·March 17, 2011

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 31, 2008

    EASYPUMP: LT 270-132: 270 ML, 22ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code MEB·November 7, 2014

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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