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

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    MOSFET AUTOSENSE WIRELESS

    FDA 510(k)
    FDA Class 2 ·Radiology

    HairCheck-DT (Opiates)

    FDA UDI
    Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032725·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm B...

    MICROTECH

    FDA registration
    MICROTECH·1 product·🇺🇸 United States

    MICROPAQ, MODELS 402 AND 404

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES

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

    MOSAIC

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025

    INFINITY VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 29, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 29, 2011

    AC TENDER II

    FDA Adverse Event
    Death ·UNOMEDICAL A/S·Product code FOZ·April 7, 2008

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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