BEUDAMED
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    COBAS INTEGRA ONLINE DAT II COCAINE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496023296·NAOMI 100, SIZE XXL, CAMEL, GRADUATED COMPRESSI...

    BIOMET SCK KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOSS MIAMI SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 27, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 18, 2011

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GAG·April 1, 2008

    NUTRILINE TWINFLO 24G 30CM DUAL LUMEN CATHETER W/ STYLET, GRIP-LOK, & MICROFLASH

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·June 21, 2019

    NUTRILINE

    FDA Adverse Event
    Malfunction ·VYGON MFG·Product code LJS·February 28, 2019

    NUTRILINE

    FDA Adverse Event
    Malfunction ·VYGON MFG·Product code LJS·January 29, 2019

    ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·August 1, 2017

    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