BEUDAMED
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    ClearRead CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221612150·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221612000·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221612070·

    ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Unison®-C Anterior Cervical Fixation System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468083342·Interbody Fusion Device, 22mm (W), 16mm (D), 12...

    Unison®-C Anterior Cervical Fixation System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468080853·Interbody Fusion Device, 22mm (W), 16mm (D), 12...

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 2, 2016

    Unison®-C Anterior Cervical Fixation System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468081737·Trial, 22mm (W), 16mm (D), 12mm (H), 7° Lordosis

    Unison®-C Anterior Cervical Fixation System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468082291·Rasping Trial, 22mm (W), 16mm (D), 12mm (H), 7°...

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 3, 2014

    EXETER V40 STEM 37.5MM NO 0

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·August 19, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 9, 2013

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code OJK·October 15, 2024

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Enforcement
    Class III ·Terminated·Michigan Instruments, Inc.·May 16, 2018