BEUDAMED
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    Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105

    FDA Recall
    Terminated ·Cook Endoscopy·Product code KOG·April 20, 2006

    Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·August 4, 2006

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Recall
    Terminated ·Ceg Enterprises Llc·Product code MCF·April 5, 2016

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Enforcement
    Class II ·Terminated·Ceg Enterprises Llc·June 29, 2016

    X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012

    FDA Recall
    Terminated ·X-Cel X-Ray Corp·Product code KPR--·November 12, 2002

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

    FDA Enforcement
    Class II ·Terminated·Associates of Cape Cod, Inc.·May 22, 2019

    Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

    FDA Enforcement
    Class II ·Terminated·Associates of Cape Cod, Inc.·September 28, 2022

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·February 18, 2015

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012

    IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·November 11, 2010

    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAD·April 21, 2016

    IMMULITE /IMMULITE 1000 Vitamin B12

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018

    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code CEC·November 8, 2013

    Dimension Free Thyroxine (FT4L) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018