BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    NUTRIMIX MACRO TPN COMPOUNDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257010006·M.3 SOFT OA BRACE, VARUS, LEFT, LG

    Pedo OnBrace Crown UL4 (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199014040·

    RP Standard Healing Abutment, 4.0mm, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107757·Healing Abutments are intended for placement on...

    VADI MEDICAL

    FDA UDI
    VADI MEDICAL TECHNOLOGY CO., LTD.·04719894386324·

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111449·3M™ Victory Series™ First Molar Bands Kit, Uppe...

    Rampart One Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7404901404·Rampart One Standard Spacer

    Miracle Suctions with Mirror

    FDA UDI
    DiaDent Group International·08806383524476·Multifunctional Mirror with Suction

    Elite®Opti-MIM® Bondable Buccal Tubes

    FDA UDI
    Ortho Organizers, Inc.·00190707070182·.018 U6L STD OPTI-MIM -14T DB

    IVUE, MODEL 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    UNKNOWN

    FDA Adverse Event
    WILLIAM COOK EUROPE·Product code DTK·October 27, 2015

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·October 29, 2010

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·December 21, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012