BEUDAMED
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    CareEvent

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KELMAN-HOFFER SUTURE TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896015777·KELMAN-HOFFER SUTURE TISSUE FORCEPS WITH TYING ...

    GEMINI GXL

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 28, 2011

    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015