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

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    LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Enforcement
    Class II ·Terminated·LDR Spine USA, Inc.·October 12, 2016

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDZ·March 21, 2018

    IMMULITE 2000 Total Testosterone Kit

    FDA Recall
    Terminated ·Diagnostic Products Corp.·Product code CDZ·January 3, 2006

    VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) 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 DLZ·June 12, 2013

    Clinical Chemistry Phenobarbital, list number 1E08

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DLZ·November 16, 2012

    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018

    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·November 30, 2018

    VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DLZ·June 23, 2011

    VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DLZ·March 14, 2013

    Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDZ·July 26, 2010

    ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018

    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DLZ·July 30, 2012

    ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CDZ·April 18, 2017

    VIDAS Testosterone, Ref 30418

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code CDZ·May 15, 2017

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019