BEUDAMED
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    ORAL/ENTERAL SYRINGES

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

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120274·Guidewire 0.9x100mm Dbl Trocar

    Suzuka Interbody Fusion System

    FDA UDI
    Altus Spine, LLC·00843210133355·Suzuka Module Lid

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120281·Guidewire 0.9x100mm Sgl Trocar Gold Tip

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120298·Guidewire 0.9x100mm Sgl Trocar

    CAMLOG SCREW IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·May 6, 2025

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·May 16, 2011

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 9, 2023

    CLARITY CONSOLE

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY-SAN JOSE·Product code LLZ·January 7, 2019

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    FDA Adverse Event
    Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021

    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021

    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021

    Aurora Series, Aurora 7 lighthead; Models: LED7 (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

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020