BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    Volumat Line

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776155360·SWITCHING STICK/PROBE ROUND ENDS 3MM DIA 30CM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694015103·1.1mm Pilot Drill, 6mm Stop, Midas Rex

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180152083·3MM DIA., 17CM, INCISION WOUND CLOSURE DEVICE, ...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153160502·SCREWDRIVER BLADE

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946049119·X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE...

    MODIFICATION TO VISTA STEREOSCOPE SYSTEM

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

    MEDIGUIDE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 3, 2008

    HM II LVAS EUROPE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·August 16, 2011

    PROMOTE RF CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026