BEUDAMED
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    Filters FDA Enforcement × Status: Terminated × Clear all

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    Albumin Gen.2, Catalog 05166861190

    FDA Enforcement
    Class III ·Terminated·Roche Diagnostics Operations, Inc.·October 21, 2020

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019

    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·June 13, 2018

    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 23, 2016

    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015

    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device

    FDA Enforcement
    Class II ·Terminated·Pride Mobility Products Corp·January 11, 2017

    COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 23, 2016

    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·October 16, 2019

    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·October 16, 2019