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

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    ESOP HA FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reicodent

    FDA UDI
    devemed GmbH·04061644046072·EXTRACT 1100 - Extracting forceps # 8 Biscuspids

    Reicodent

    FDA UDI
    devemed GmbH·04061644046089·EXTRACT 1100 - Extracting forceps # 8 Biscuspids

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·November 8, 2021

    MEDPOR COATED TEAR DRAIN

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 24, 2021

    PERITONEAL CATHETER

    FDA Adverse Event
    Death ·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·May 24, 2021

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·June 13, 2022

    AUTO ENDO5 ML

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·August 8, 2017

    PERITONEAL CATHETER

    FDA Adverse Event
    Injury ·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·May 19, 2021

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 18, 2021

    PORTEX SPINAL ANESTHESIA TRAYS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code CAZ·March 15, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 16, 2011

    EAGLE 4000

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·March 20, 2008

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·March 27, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·May 21, 2021

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018