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

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    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

    TopCare Clifford THE BIG RED DOG power toothbrush for kids!

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·December 25, 2024

    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·February 26, 2025

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·February 26, 2025

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·February 26, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·December 25, 2024