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

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    HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040066635·Endoflex NT K-Files 21mm

    Vantage

    FDA UDI
    Exactech, Inc.·10885862655653·Special Vantage Sharp Reamer, Helix Blade, Flat...

    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VERTEX SEALAND L/C ORTHODONTIC SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    XPS® BUR - STYLUS TRANSNASAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017

    HT70 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENT·Product code CBK·March 15, 2013

    UNKNOWN DEPUY 50X32MM +4 LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 24, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMITLON BONADUZ AG·Product code JTC·February 8, 2008

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·March 3, 2023

    BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 5, 2020

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020