BEUDAMED
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    MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810037831·PASTE FILLERS RA

    BD NEXIVA, BD Q-SYTE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·June 4, 2025

    DIRECT TIBC CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FIXION INTERLOCKING NAIL (FIXION IL NAIL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 4, 2025

    HEYER-SCHULTE SALINE MAMMARY PROSTHESIS, 240 CC

    FDA Adverse Event
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FWM·October 24, 1994

    SURGITEK MAMMARY IMPLANT, 300 CC

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·October 24, 1994

    ANATOMIC SHOULDER PROSTHESIS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·January 17, 2025

    2520274-2013-01470

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 14, 2013

    UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSA·February 24, 2011

    ABBOTT CLINICAL CHEMISTRY ICT CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·August 12, 2014

    NATURAL Y POLYURETHANE MAMMARY IMPLANT, 350 CC

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·October 24, 1994

    LO-PRO LOCK SCRW TI 4.5X16MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·May 3, 2024

    LO-PRO LOCK SCRW TI 4.5X16MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·May 3, 2024

    LO-PRO LOCK SCRW TI 4.5X16MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·May 3, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024