BEUDAMED
    15 results · 12ms · Sources: EU EUDAMED, US FDA

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    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Enforcement
    Class II ·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017

    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

    FDA Recall
    Terminated ·Ortho Solutions Inc 330 Franklin Tnpk·Product code HWC·July 14, 2015

    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Enforcement
    Class II ·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017

    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·November 25, 2015

    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

    FDA Enforcement
    Class II ·Terminated·Sterilmed, Inc.·October 17, 2018

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    FDA Enforcement
    Class II ·Terminated·Cell Marque Corporation·June 7, 2017

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    FDA Enforcement
    Class III ·Terminated·Biofire Defense·March 11, 2020

    OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.

    FDA Enforcement
    Class II ·Terminated·ZOLL Medical Corporation·March 21, 2018

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Enforcement
    Class II ·Terminated·AB ULAX·October 14, 2020

    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 13, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012