BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    COULTER CELLPREP

    FDA 510(k)
    FDA Class 1 ·Hematology

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00037741702122·

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311210299·Tap, Cann, 11.5

    ReverseTM

    FDA UDI
    Reverse Medical Corporation·00847536003552·MIC-021-150 REVERSE MICROCATHETER

    ReverseTM

    FDA UDI
    Reverse Medical Corporation·00847536021945·MICROCATHETER MIC-021-150 REVERSE

    DRIDAU OPIATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 26, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011

    EAGLE 4000

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

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·October 12, 2021

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code GEX·August 30, 2021

    SETSCREW

    FDA Adverse Event
    Malfunction ·Product code NKB·September 22, 2023

    21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXZ·February 1, 2010

    21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXZ·February 1, 2010

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    FDA Adverse Event
    Injury ·ZEALAND PHARMA U.S. INC.·Product code LZG·March 25, 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