BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    ADVANTAGE WINDOWS CT/PET FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vivid NanoCeram Bright flow

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724D0103361·2x 2gm

    GC Initial™

    FDA UDI
    Gc America Inc.·14548161315067·GC Initial™ LiSi Press Ingot LT-A (3g x 5)

    GC Initial™

    FDA UDI
    Gc America Inc.·D0470103361·GC Initial™ LiSi Press Ingot LT-A (3g x 5)

    N/A

    FDA UDI
    Ortho Development Corporation·00822409133192·Modular Femoral Head Impactor

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450096901·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103060·Shaver, Closed, 6mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024014·Paddle Shaver, 6mm

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    FDA 510(k)
    FDA Class 2 ·Immunology

    DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·December 9, 2025

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    HEARTSTART ONSITE

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2013

    OLYMPUS HIGH FREQUENCY ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GEI·February 11, 2011

    4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 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

    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