BEUDAMED
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    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Recall
    Terminated ·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Enforcement
    Class II ·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code JOY·May 2, 2016

    cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports the following parameters: RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, %NRBC, #NRBC, WBC, %NEUT, #NEUT, %LYMPH, #LYMPH, %MONO, #MONO, %EO, #EO, %BASO, #BASO, PLT, MPV, %RET, #RET, HGB-RET.

    FDA Recall
    Terminated ·Roche Diagnostics Hematology·Product code JOY·May 7, 2018

    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC

    FDA Recall
    Terminated ·Integrated Measurement Systems, Inc.·Product code FRW·January 30, 2007

    Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.

    FDA Recall
    Terminated ·Rayes Inc·Product code FNL·November 14, 2005

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    Savaria SL-1000 Stairlift

    FDA Enforcement
    Class II ·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017

    TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    Omega Incline Platform Lift

    FDA Enforcement
    Class II ·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017

    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

    FDA Enforcement
    Class II ·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017