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

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    Prelude SNAP Splittable Sheath Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550209·GENUMEDI PT KNEE SUP SILVER R EW V

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052016272·Aggressive Full Radius Resector 5,5-15°gebogen

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V

    VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELLIPSE LIGHT SPT

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

    THRUWAY GUIDE WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·October 6, 2014

    TERUMO GLIDESHEATH BASIC

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORP.·Product code DYB·May 9, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 28, 2011

    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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