BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    CUSTODIOL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032794·Baltic Denture System BDLoad Mn7 PLSEbim6DFm A3...

    CombiSet Twister

    FDA UDI
    Fresenius Medical Care Holdings, Inc.·00840861100316·Pre-pump, 8.0 mm, with Twister® Reverse Access ...

    COMBISET ACCESS FLOW REVERSE CON TWISTER

    FDA Adverse Event
    Death ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KOC·January 12, 2018

    PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OASYS BLOCKER

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015

    FLEXI-SEAL FMS

    FDA Adverse Event
    Other ·CONVATEC·Product code KNT·June 7, 2006

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 3, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·April 23, 2008

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

    COMBISET ACCESS FLOW REVERSE CON TWISTER

    FDA Adverse Event
    Malfunction ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KOC·June 4, 2025

    FMC BLOODLINE

    FDA Adverse Event
    Malfunction ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code FJK·May 29, 2018

    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device

    FDA Recall
    Terminated ·Fresenius Medical Care North America·Product code KOC·November 25, 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

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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