BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Caiman Seal and Cut Technology

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100639·CHU FEMTO SPECULUM LARGE

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962105184·ETHOS MEDIAL ANCHOR, PEEK, 5.5mm x 15mm, (2) #2...

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·10842962105181·ETHOS MEDIAL ANCHOR, PEEK, 5.5mm x 15mm, (2) #2...

    MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPAL BAND CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·December 21, 2015

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 5, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 6, 2011

    VWNG

    FDA Adverse Event
    VITAL ACCESS·Product code PFH·May 24, 2013

    ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

    FDA Adverse Event
    Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3

    FDA Adverse Event
    Death ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·November 25, 2015

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014