BEUDAMED
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    PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Osseoscrew

    FDA UDI
    ALPHATEC SPINE, INC.·00811801038648·Osseoscrew Trial Probe, Right

    Phonak

    FDA UDI
    Sonova AG·07613275614112·Phonak Naída B50-SP (beige)

    Speed-Lock

    FDA UDI
    STRYKER CORPORATION·07613327057812·Cannula Plug for 4 mm Arthroscope

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0319010·CR Tibial Insert, UHMWPE + Vitamin E, Size 3, ...

    FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 12, 2026

    SMARTNAIL

    FDA Adverse Event
    Injury ·CONMED CORPORATION·Product code MAI·July 29, 2019

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 28, 2013

    RADIAL JAW 4 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·March 28, 2011

    ASCENSIA CONTOUR

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

    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