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

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    VASO PRESS DVT FOOT GARMENT #VP 520

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM 1.5ML RESERVOIR, MODEL 326

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

    KYPHX® HV-R? BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014

    KYPHX® HV-R? BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014

    UCSS

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·March 14, 2013

    LAMITRODE 44C SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 24, 2011

    FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·February 26, 2008

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

    GUIDE, SURGICAL, INSTRUMENT

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024

    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