BEUDAMED
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    MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820705510·FORCEPS

    Theragenics

    FDA UDI
    THERAGENICS CORPORATION·00813787021812·

    Mick 5mm gold fiduciary marker,17G,single (10pc)

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330021458·

    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMAGE X-70 PLUS DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    HOOK OR SCREW HOLDER

    FDA Adverse Event
    Malfunction ·SYNTHES JENNERSVILLE·Product code LXH·April 22, 2013

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·April 15, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2008

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

    Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GEI·November 16, 2007

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    FDA Enforcement
    Class II ·Terminated·Mazor Robotics Ltd·January 1, 2020

    Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GEI·February 25, 2010

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022