BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112110·Tap, Cannulated, 4.75 mm

    FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    CoverLoc™ Volar Plate

    FDA UDI
    TORNIER, INC.·00846832001156·VOLAR PLATE

    ROLLO 112X10X12E.PRINTER

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763004844·

    GLACIER

    FDA UDI
    SDI LIMITED·DO3670112111·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0110110·Sounder, Ball Tip, Straight, Firm, Titanium

    MODIFICATION TO INTRALASE 600C LASER KERATOME

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

    STERILE NITRILE POWDER-FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·January 30, 2025

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

    PRECISION XTRA / OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 11, 2007

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·March 19, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 8, 2011

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    INTACS CORNEAL IMPLANTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015