BEUDAMED
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    WESTMED RESPIRATORY LUER ADAPTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Coulmed

    FDA UDI
    Coulmed Products Group LLC·10810087350274·Standard Sterile Surgical Gown, X-Large, AAMI 3

    Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

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

    CONVERTORS SAFECARE GOWN & DRAPE MATERIAL

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

    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·December 18, 2019

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 9, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 5, 2011

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·July 23, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017