BEUDAMED
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    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126653·15-20 MV FOR MEN SEL CALF STD BLACK VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257124680·15-20 MV FOR MEN CLSC CALF STD BLACK VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141199·15-20 MFW VITALITY CALF CT EBONY VI

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742110738·LYNX ø3.5mm Std Cortical Screw, Full Thread, Se...

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2020

    SYNTHES ANTERIOR CSLP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SMARTPLUG

    FDA Adverse Event
    Other ·MEDENNIUM, INC.·Product code LZU·March 14, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 18, 2011

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·May 9, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024