BEUDAMED
    23 results · 9ms · Sources: EU EUDAMED, US FDA

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    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017

    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKJ·April 3, 2017

    TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003

    Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.

    FDA Recall
    Terminated ·Novoste Corporation·Product code JAJ·January 25, 2002

    VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DKJ·June 12, 2013

    COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKJ·December 15, 2005

    Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code DKJ·December 5, 2006

    SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DKJ·October 22, 2007

    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

    FDA Recall
    Terminated ·Microgenics Corporation·Product code DKJ·July 25, 2016

    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014

    VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014

    VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 10, 2014

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 25, 2014

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code 000·May 7, 2012

    Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code JWH·September 19, 2017

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Enforcement
    Class II ·Terminated·JK Products & Services, Inc·August 22, 2012

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Enforcement
    Class II ·Terminated·JK Products & Services, Inc·September 19, 2012

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Enforcement
    Class II ·Terminated·JK Products & Services, Inc·September 24, 2014