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

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    POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    6LE7P Ultrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904087818·

    ENDOPATH, 7/8 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·April 20, 1994

    HELIODENT VARIO

    FDA 510(k)
    FDA Class 2 ·Dental

    POLYESTER NONABSORBABLE SURGICAL SUTURES URP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC RICE CREEK MFG·Product code LWS·August 4, 2017

    EON MINI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    SCORPIO NRG X3 PS TIBIAL INSERT #9 15MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·February 22, 2011

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 15, 2008

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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

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

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