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

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    BCLEAR

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040161965·Channels Flex Paper Points 15.04

    eSensor® XT-8

    FDA UDI
    GENMARK DIAGNOSTICS, INC.·00857167005047·eSensor® Warfarin Sensitivity Test Cartridge Po...

    DIMENSION PENTA H, DIMENSION PENTA H QUICK

    FDA 510(k)
    FDA Class 2 ·Dental

    COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2013

    FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·January 17, 2018

    LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 17, 2018

    KINECTIV® MODULAR NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 17, 2018

    MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 13.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 17, 2018

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH·Product code LWS·March 21, 2013

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·February 10, 2011

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 28, 2008

    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 13, 2015

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 14, 2013

    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