BEUDAMED
    14 results · 36ms · Sources: EU EUDAMED, US FDA

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    EyeBOX (Model EBX-4)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ETHIBOND

    FDA UDI
    DEPUY MITEK, LLC·10886705002047·Rotator Cuff EasyAnchor Size 2 (5 metric) green...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730007667·Votion 018 MC UL3 HK -7T 8A 0O (10PK)

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113353·Votion .018 MC UL3 HK -7T 8A 0O (10PK) VOTION

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821231000101·EXPERIENCE Mini ROTH 022/LL1&2-1T 2A

    WONDFO METHADONE URINE TEST,OPIATE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·August 15, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023