BEUDAMED
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    MEDGEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Healqu

    FDA UDI
    Healqu LLC·00819143020390·HEALQU Non-Woven Adhesive Border Foam Dressing ...

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 11, 2019

    Solidity Vertebral Body Replacement

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386022385·End cap, Ø 16mm, 5°

    Acapella One

    FDA UDI
    Choice Spine, LP·10885862244857·

    EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REPROCESSED ATHROSCOPICS BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS INTEGRA 400 PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2013

    AUTOSONIX HOOK PROBE LONG

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code LFL·March 10, 2011

    TORQUE LIMITING HANDLE

    FDA Adverse Event
    Malfunction ·EBI·Product code HXC·March 25, 2008

    Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code GEH·April 29, 2004

    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