BEUDAMED
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    STA COMPACT MAX

    FDA 510(k)
    FDA Class 2 ·Hematology

    MONOPOLY/CONKLUSION

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844008188·The CONKLUSION Pedicle Screw System is a spinal...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175788·Z-Rod, Dia. 6.0mm, Titanium, 90mm

    H2 HEATED HUMIDIFIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMPLANTABLE CLIP

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

    SIGMA

    FDA UDI
    ALPHATEC SPINE, INC.·00190376395180·SIGMA MEDIALIZED, 90 mm TLIF POST, RIGHT

    SIGMA

    FDA UDI
    ALPHATEC SPINE, INC.·00190376464725·90 mm NARROW BLADE, LEFT, SIGMA MEDIALIZED

    SIGMA

    FDA UDI
    ALPHATEC SPINE, INC.·00190376464732·90 mm NARROW BLADE, RIGHT, SIGMA MEDIALIZED

    SIGMA

    FDA UDI
    ALPHATEC SPINE, INC.·00190376395173·SIGMA MEDIALIZED, 90 mm TLIF POST, LEFT

    Widex

    FDA UDI
    Widex A/S·05706069556445·Widex D-FA P (Metallic Blue ) Dream 330, Teleco...

    Widex

    FDA UDI
    Widex A/S·05706069553758·Widex UNIQUE U-FA (Metallic Blue ) 330, Telecoi...

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

    STRATA 2 VALVE, REGULAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·May 21, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    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

    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

    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