BEUDAMED
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    USA SERIES LAPAROSCOPES

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

    FRYE & CO

    FDA UDI
    FGX INTERNATIONAL INC.·00193033483107·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

    Brisbane Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215044220·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197026604·Standard Operating Scissors Fig. 2 curved...

    VITALSAT PULSE OXIMETER, MODEL IC32000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERO SCAN OAE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·October 21, 2020

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981105730·Tap - 6.5mm

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981111052·Cannulated Tap 6.5mm

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR·Product code MJN·March 13, 2008

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

    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, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    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