BEUDAMED
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    BI-ANGULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMDS Hybrid Prosthesis ("AMDS")

    FDA UDI
    Artivion, Inc.·00877234001338·40mm (Classic) Straight Stent (28mm collar)

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032895·Baltic Denture System BDLoad ↓ Mm7 PLSEum2DFm B...

    HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELCAM STOPCOCKS AND MANIFOLDS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    NKS PM-L

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

    DIDECO COMPACTFLO EVOLUTION OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 3, 2013

    FLEXICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·March 29, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·April 23, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa Openspeed with Excite Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the open design of the system, the Signa 0.7T Signa OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles. . .

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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024