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

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    ULTRAMAXO2 OXYGEN ANALYER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Alpine SL

    FDA UDI
    Rmo, Inc.·00885797695741·ROTH ALPINE SL CLEAR 022 HK/345 MN2PCBIC 20EA

    2550 BALLOON VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750008704·2550C 4WAY INFLBAL 1.375 OD

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277129246·Carpal Tunnel Release Blade Set of 2

    TLIF/PLIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837086787·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857531185·T-handle Size 30 mm

    OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 14, 2013

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 24, 2014

    SEQUENTIAL COMPRESSION DEVICE

    FDA Adverse Event
    Malfunction ·HUNTLEIGH HEALTHCARE·Product code JOW·May 29, 2011

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012

    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021