BEUDAMED
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    CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776178338·HANK DILATOR FR

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    WAKO AUTOKIT LP(A)/ RA,500/1000,

    FDA 510(k)
    FDA Class 2 ·Immunology

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

    CRUCIFORM SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·April 3, 2013

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·March 28, 2011

    S/L PERC 7 FR 65D

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD)·Product code LJS·April 17, 2008

    OSS POLY TIBIAL BUSHING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 26, 2017

    OSS POLY BUMPER LOCK PIN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 26, 2017

    OSS TIBIAL POLY BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 26, 2017

    OSS REINFORCED YOKE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 26, 2017

    OSS POLY FEMORAL BUSHINGS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 26, 2017

    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