BEUDAMED
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    SHARPOINT LUKENS BONE WAX

    FDA 510(k)
    FDA Unclassified ·Unknown

    PYRAMESH® C Titanium Mesh

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074471587·MESH-MACH-KIDNEY-10X32X8-4

    PULSE

    FDA UDI
    Nuvasive, Inc.·00195377052414·PULSE Inserter, Patient Reference Array

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496050292·RED WELLNESS 70 LEGGINGS, SIZE L, LONDRA, GRADU...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450294697·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450309940·

    BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRX 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    12X100MM KII BALLOON BLUNT TIP SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·April 5, 2013

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    PERFIX PLUG

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 22, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014