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

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    CYBERWAND STERILE PROBE SET

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

    GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGNATURE PLANNER; SIGNATURE GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 24, 2023

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·May 16, 2013

    EON

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL, NEUROMODULATION·Product code GZB·September 29, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2011

    7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·August 12, 2020

    MPACT ACETABULAR SHELL Ø 52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 15, 2016

    SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 26, 2012

    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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015