BEUDAMED
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    EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809282815690·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390865357·

    POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    XBO1-824-18/19/20 BIOPSY FORCEPS

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

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 16, 2023

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 2, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 2, 2011

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 5, 2008

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·December 6, 2018

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 11, 2020

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021