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

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    COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450263143·

    ELRAN 01 SYSTEM

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

    LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 15, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·March 9, 2011

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·March 13, 2008

    COMP LK SCR 3.5HEX 4.75X30 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 27, 2021

    COMP LK SCR 3.5HEX 4.75X30 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 27, 2021

    COMP NLK SCR 3.5HEX 4.75X30 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 27, 2021

    COMP AUG MINI BSPLT W TPR MD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 8, 2021

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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

    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