BEUDAMED
    57 results · 13ms · Sources: EU EUDAMED, US FDA

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    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LRO·January 31, 2020

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Enforcement
    Class II ·Terminated·AB ULAX·October 14, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LRO·January 31, 2020

    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

    FDA Enforcement
    Class II ·Terminated·Lymol Medical Corporation·October 6, 2021

    Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc.·Product code JJE·May 15, 2020

    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

    FDA Recall
    Terminated ·Lymol Medical Corporation·Product code EOQ·July 29, 2021

    Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc.·Product code JJE·May 15, 2020

    HEMO-7 Hemospray Endoscopic Hemostat

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·April 29, 2020

    HEMO-10 Hemospray Endoscopic Hemostat

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·April 29, 2020

    Pneupac paraPac plus 300 ventilator kit, REF P300NGB

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code BTL·July 15, 2021

    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 25, 2020

    WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·December 15, 2020

    Thora-Para 5 Fr Catheter Drainage Tray

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code PXI·May 28, 2020

    Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code PXI·May 28, 2020

    Safe-T-Centesis 6 Fr Catheter Drainage Tray

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code PXI·May 28, 2020

    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code PXI·May 28, 2020