BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427071·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427095·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427088·

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025

    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·July 23, 2010

    BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (70 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMF·April 20, 2023

    130 DEG LCP DHHS(TM) SIDEPLATE-SHRT BARREL 4H-STER

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code KTT·March 20, 2013

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL INTERNATIONAL LTD·Product code BTR·February 28, 2011

    VERSACARE BED WITH PRIME AIR MATTRESS

    FDA Adverse Event
    HILL-ROM COMPANY, INC.·Product code FNL·January 31, 2008

    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·July 31, 2024

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024