BEUDAMED
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    Fresenius Liberty Select Cycler

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

    HEALIX ADVANCE ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705021543·HEALIX ADVANCE PEEK MULTIPACK - 3 SUTURE (5) PE...

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464010912·HEARLINK 9030 MNR T R BL DEMO

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113614·PS-C Insert, Size 3 x 18mm

    ZAVATION CONNECTOR

    FDA UDI
    Zavation LLC·00197157021139·Open-Open/Large-Small 18mm Offset Connector

    Marathon Flow Directed Micro Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES

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

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996161299·AMBASSADOR,DRILL,2.3x18

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2019

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 26, 2019

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GFF·July 12, 2013

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2019

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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