BEUDAMED
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    COSENSE CO MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012905·AUSTIN EXCAVATOR RIGHT

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707010098·CALIBRA 1ST MOLAR BANDS n.UL 36

    Invictus

    FDA UDI
    ALPHATEC SPINE, INC.·00190376610696·Universal Variable Medial Cross Connector, 36mm...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197044066·Cushing Dressing Forceps straig...

    TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ALLOFUSE PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 27, 2025

    COHERENT

    FDA Adverse Event
    Malfunction ·CLINICAL RESEARCH CONSULTANTS, INC.·Product code GEX·January 23, 2013

    *

    FDA Adverse Event
    BIOLITEC MEDICAL DEVICES INC·Product code GEX·February 4, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 24, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 30, 2014

    FIXED DURAGUARD, 25MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·May 5, 2011

    HNM LATERAL ANCHOR

    FDA Adverse Event
    Injury ·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 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

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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