BEUDAMED
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    PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TISSUE FORCEPS ADSON 6" STRAIGHT SERRATED

    FDA UDI
    W.H. Holden, Inc.·D9281300880·

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

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

    TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·April 23, 2020

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 13, 2019

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·May 24, 2013

    ALTERNATING PRESSURE AIR FLOTATION MATTRESS

    FDA Adverse Event
    GRAND HEALTHCARE CO., LTD.·Product code FNM·September 30, 2014

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·October 18, 2019

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·March 26, 2020

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 4, 2022

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015