BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·October 31, 2012

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Enforcement
    Class II ·Terminated·Organon Teknika Inc·March 6, 2019

    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

    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

    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

    FDA Enforcement
    Class II ·Terminated·Diasorin Inc.·November 30, 2016

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    FDA Enforcement
    Class II ·Terminated·Neocis, Inc.·February 3, 2021

    VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 28, 2018

    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).

    FDA Enforcement
    Class II ·Terminated·Genetic Testing Institute,inc·April 3, 2013

    LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.

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

    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.

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

    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·July 24, 2019