BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    ESTECH CLEARVIEW MV ATRIAL DEPRESSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MiniKut

    FDA UDI
    DENTAL ENGINEERING LABORATORIES, LLC·00850001745444·MiniKut Rotary NiTi Endodontic Files .30/.05, 2...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00530211·

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005137·SST TWIST DRILL, AO TYPE, 2mm DIA. X 100mm

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809845068·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE MEDIUM B...

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

    MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHTLANCE LASER SKIN PERFORATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    DISC CONDYLE KIT W/ HEXALOBULA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDC·April 11, 2013

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    FUHRMAN PLEURAL/ PNEUMOPERICARDIAL DRAINAGE SET AND TRAY

    FDA Adverse Event
    Malfunction ·COOK CRITICAL CARE·Product code KDQ·May 19, 2008

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 5, 2013

    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 29, 2014