BEUDAMED
    26 results · 14ms · Sources: EU EUDAMED, US FDA

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    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 18, 2020

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWG·April 8, 2020

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWD·December 11, 2020

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·June 17, 2020

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·February 3, 2021

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2015

    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

    FDA Recall
    Terminated ·Covidien LLC·Product code MGQ·March 3, 2017

    Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***

    FDA Recall
    Terminated ·DeRoyal Wound Care·Product code MGQ·July 8, 2004

    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Amerigel Daily Dressing Packets Wound management

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·September 26, 2014

    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LGQ·November 17, 2003

    AEROSET Phenobarbital, LN 1E08-01

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code LGQ·November 3, 2003

    Amerigel Wound Dressing 55 gallons/drum

    FDA Recall
    Terminated ·Kova Laboratories, Inc.·Product code MGQ·March 21, 2014

    Amerigel Wound Dressing 1 oz. tube

    FDA Recall
    Terminated ·Kova Laboratories, Inc.·Product code MGQ·March 21, 2014

    Amerigel Saturated Gauze Dressing Wound management

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·September 26, 2014

    Amerigel Hydrogel Wound Dressing Wound management

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·September 26, 2014

    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Amerigel Post-op Surgical Kits Wound management

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·September 26, 2014