BEUDAMED
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    TROJAN EXTRA LARGE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CovaWound™ Silicone 12x12

    FDA UDI
    Covalon Technologies Ltd·00825439011508·Self-Adherent Soft Silicone Foam Dressing

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00887517234018·Universal Broach, 12x18mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062456·Endoflex Reamers 25 mm

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001212·artVeneer life upper anteriors, IL, B2

    PROLITE

    FDA UDI
    Atrium Medical Corporation·00650862300109·ProLite Mesh, 12in. x 12in. (30.5cm x 30.5cm)

    SCANLAN® Endoscopic TIP-GUARD™ instrument protectors - Clear

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001969·SCANLAN® Endoscopic TIP-GUARD™ instrument prote...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756029612·LAPAROTOMY SPONGES

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370012120·Health-Tec/DHP Elevator Heidbrink 3

    MIO

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 29, 2013

    DIGITAL INTEGRATION SYSTEM, DIS2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    KSEA CHARDONNES MORCELLATION KNIFE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    DLP AORTIC ROOT CANNULAE

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code DWF·September 24, 2014

    IMPLANT DRIVER HOLDER ASSEMBLY

    FDA Adverse Event
    Malfunction ·OSTEOMED LP·Product code MDM·June 16, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 8, 2013

    FOXCROSS PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·February 24, 2011

    ASSY, SPEAKER

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·February 22, 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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013