BEUDAMED
    8 results · 16ms · Sources: EU EUDAMED, US FDA

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    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol

    FDA Recall
    Completed ·Pintler Medical LLC·Product code DWJ·April 20, 2018

    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol

    FDA Enforcement
    Class II ·Completed·Pintler Medical LLC·April 24, 2019

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·October 18, 2017

    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·November 15, 2017

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020

    AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024

    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024

    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024