BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679696·SPACER 4991432 CONTROL PTC 0 DEG 14X32

    CAPSTONE® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994290908·SPACER 2991432 CAPSTONE PEEK 14X32

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169055476·SPACER 3991432 CAPSTONE IR 0 DEG 14X32

    CAPSTONE® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·April 17, 2014

    XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01

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

    cortiQ PRO

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTERLOCK¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·March 6, 2013

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·August 8, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSTONE SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·February 15, 2018

    CAPSTONE PEEK VERT BODY SPACER

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·October 9, 2020

    CAPSTONE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·February 23, 2021

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·March 30, 2011

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Recall
    Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016