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

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    TONE-A-MATIC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003254·1.6mm Pre-bent Plate, 6mm step, Left

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450186954·

    Invictus

    FDA UDI
    ALPHATEC SPINE, INC.·00190376610719·Universal Variable Medial Cross Connector, 52mm...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064095·1.6 OSA 6mm Pre-bent Left Plate Sterile Qty 2

    OSTIM

    FDA 510(k)
    FDA Class 2 ·Dental

    V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE

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

    CAPIOX®FX

    FDA Adverse Event
    Death ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 27, 2025

    STERRAD 200 STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·May 24, 2013

    UNKNOWN DEPUY DURALOC ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 30, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·June 18, 2019

    4.5MM CORTEX SCREW SELF-TAPPING 34MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 10, 2018

    ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 29, 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

    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

    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