BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    GALIX PACESTAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

    Reicodent

    FDA UDI
    devemed GmbH·04061644049042·Side cutter | 14 cm for soft wires up to 1.3 mm...

    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    BONART ART-E1 ELECTROSURGERY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    CAVITRON JET PLUS TAP-ON(DNA) G137

    FDA Adverse Event
    Malfunction ·DENTSPLY LLC·Product code ELC·February 14, 2024

    ACUITY CENTRAL MONITORING

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 27, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·February 24, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020