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

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    SNOWPOST, SNOWLIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056479·Zirlux Multi Anterior B1,98.5X25

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123541·G-aenial Univ. Injectable Unitip B2

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450253182·

    SIGHT STATION

    FDA UDI
    FGX INTERNATIONAL INC.·00031568122323·

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T-SLING

    FDA Adverse Event
    Injury ·HERNIAMESH S.R.L.·Product code PAH·March 7, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 9, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·February 12, 2008

    Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    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

    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