BEUDAMED
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    X-RAY SYSTEM XR-MX

    FDA 510(k)
    FDA Class 2 ·Radiology

    Duesseldorf Type AERIAL Total Titanium

    FDA UDI
    Heinz Kurz GmbH·EHKM10040371·Ossicular Prosthesis, total

    artegral life HD

    FDA UDI
    Merz Dental GmbH·D7092004037·artegral life HighDefinition posterior lower -M...

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918190211·Needle Counter_Red_40-Count_Foam Block_Magnet_S...

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918173719·Needle Counter_40-Count_Foam Block_Magnet_64 ea...

    Xcel

    FDA UDI
    STRYKER CORPORATION·07613154567201·3.5MM X 24MM XCEL ANCHOR RC DRILL

    INTERVENTIONAL BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOFILAMENT BIOSYN SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·May 5, 2025

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 19, 2013

    SIGN I. M. NAIL

    FDA Adverse Event
    Injury ·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·February 23, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC. USA·Product code LFR·February 27, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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