BEUDAMED
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    COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAPONICEL™

    FDA UDI
    ADVANCED MEDICAL SOLUTIONS LIMITED·15032749040612·ACTIVHEAL® RAPONICEL™ ULTRA 10X10CM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight

    SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYCLOTEC AMT CTI TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    TESS GLENOID REVERSE HEAD DIAMETER 36

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

    FDA Enforcement
    Class II ·Terminated·International Biophysics Corp.·August 26, 2015

    ETAC HI-LOO TOILET ARM SUPPORT

    FDA Adverse Event
    Malfunction ·ETAC SUPPLY CENTER AB·Product code ILS·March 15, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·August 27, 2014

    UNKNOWN GII ANCHOR

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code JDR·October 28, 2019

    GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·November 18, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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