BEUDAMED
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    SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106402·PERL CORNEAL FORCEPS 0.08MM RIGHT

    YUSHENG DISPOSABLE VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    SETROX S 60

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·July 23, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 7, 2011

    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.

    FDA Recall
    Terminated ·Vertebral Technologies, Inc.·Product code LXH·January 13, 2017

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016