BEUDAMED
    103 results · 19ms · Sources: EU EUDAMED, US FDA

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    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017

    Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.

    FDA Recall
    Terminated ·Perkinelmer·Product code JLW·June 27, 2012

    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 9, 2012

    Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

    FDA Recall
    Open, Classified ·Navajo Manufacturing Company·Product code IRT·February 18, 2026

    Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926).

    FDA Recall
    Terminated ·HoMedics, Inc.·Product code IRT·February 9, 2007

    Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002

    FDA Recall
    Open, Classified ·Whele LLC DBA Perch·Product code IRT·October 24, 2022

    Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).

    FDA Recall
    Terminated ·HoMedics, Inc.·Product code IRT·February 9, 2007

    HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).

    FDA Recall
    Terminated ·HoMedics, Inc.·Product code IRT·February 9, 2007

    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

    FDA Recall
    Terminated ·Ergoactives, Llc·Product code IRT·January 19, 2016

    Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

    FDA Recall
    Open, Classified ·Whele LLC DBA Perch·Product code IRT·October 24, 2022