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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Qiagen Sciences, Inc.·Product code NTW·May 6, 2019

    QIAamp DSP Virus Kit Cat. No. 60704

    FDA Enforcement
    Class II ·Terminated·Qiagen, GmbH·December 27, 2017

    QIAamp DSP Virus Kit Cat. No. 60704

    FDA Recall
    Terminated ·Qiagen, GmbH Qiagen Str. 1 Hilden Germany·Product code N/A·July 22, 2017

    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences, Inc.·July 3, 2019

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·QIAGEN 19300 GERMANTOWN RD GERMANTOWN MD 20874 USA KOELN Germany·Product code JJH·May 28, 2018

    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Alcon Grieshaber AG·June 12, 2013

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·QIAGEN·August 8, 2018

    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

    FDA Recall
    Terminated ·Alcon Grieshaber AG Winkelriedstrasse 52 Schaffhausen Switzerland·Product code HQE·April 17, 2013

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Enforcement
    Class II ·Terminated·Alcon Research LLC·June 17, 2020

    Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP Part #: 7205330. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Recall
    Terminated ·Alcon Research LLC Aspex Facility·Product code HQL·April 17, 2020

    Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Recall
    Terminated ·International Medsurg Connection, Inc.·Product code FMI·June 23, 2017

    Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Recall
    Terminated ·International Medsurg Connection, Inc.·Product code FMI·June 23, 2017

    Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·January 30, 2015