BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925011588·AUSTIN PROBE 45 DEGREE TIP ANGLE 1.27 MM TIP LE...

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05065025111662·KLEOS 2 PSL METAL STANDARD TORQUE 022 LR4 PK5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003179·Right L Plate, 10mm, Rigid

    Invictus

    FDA UDI
    ALPHATEC SPINE, INC.·00190376610702·Universal Variable Medial Cross Connector, 44mm...

    FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXTENDED RANGE HS CRP KIT, CAT NO:9200

    FDA 510(k)
    FDA Class 2 ·Immunology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 24, 2013

    MAESTRO DRILL WITH HANDSWITCH

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENT KALAMAZOO·Product code HBB·May 5, 2011

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 19, 2008

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    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

    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

    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