BEUDAMED
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    CARESTREAM IMAGE SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MATHIEU NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896045996·MATHIEU NEEDLE HOLDER HEAVY TUNGSTEN CARBIDE SE...

    Vilex Guidewire

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

    Vilex Guidewire

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

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    A & I WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011

    UNKNOWN FAST-FIX 360

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·February 6, 2023

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 29, 2013

    ANIMAS INSULIN CARTRIDGE

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

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·May 16, 2011

    LL100 CRYOSURGICAL

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·April 10, 2023

    NEXGEN STEMMED TIBIAL COMPONENT FIXED BEARING PRECOAT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·January 6, 2017

    NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·January 6, 2017

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025