BEUDAMED
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    BETEC RETRACTABLE SAFETY SYRINGE (5ML)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...

    PLAINSENSE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 3, 2013

    HOYER LIFT

    FDA Adverse Event
    Other ·APEX HEALTHCARE MFG INC.·Product code FNG·March 21, 2011

    CONTOUR TS TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 15, 2008

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·April 15, 2022

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 21, 2017

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016