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

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    LUXABITE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780842·LEVAMED ACTIVE ANKLE SUP SLVR R VI

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00195995800442·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033506554·

    IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    RETINADX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CA090, DIRECT DRIVE LCA 3/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 20, 2013

    CE INTERMATE SV 100, 48 PACK,50125

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2011

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·March 12, 2008

    CFF03, 5X100 KII FIOS ADVFIX 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·September 29, 2015

    9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014