BEUDAMED
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    MULTICONSTITUENT CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oticon

    FDA UDI
    Oticon A/S·05707131167446·ACPR, ITC P PB L BE ACTO PRO

    Polyflux

    FDA UDI
    Gambro Dialysatoren GmbH·07332414036386·the Polyflux 6H is intended for chronic and acu...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·37613153045572·BONE SCREWS, EMERG., CROSS-FIT,SELF-TAPP

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857523739·Posterior Blade Size 30 mm

    SPIRA-C Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SCZ1034030·Inserter Threaded Shaft

    ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999

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

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 26, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·May 9, 2013

    MYNX

    FDA Adverse Event
    Injury ·ACCESS CLOSURE, INC.·Product code MGB·August 7, 2008

    UNKNOWN FOTA SFTWR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OUG·January 9, 2026

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906

    FDA Recall
    Terminated ·Boston Scientific Corporation·June 23, 2003

    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code OUO·April 13, 2012

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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