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

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    KMTI S141 Lumbar Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377105141·NTS Slot Tube, 20x70mm Beveled

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517187444·MaXcess Access Blade, 70mm Right

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776189150·HANDLE FOR ESOPHAGOSCOPE

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153168478·BIPOLAR FORCEPS

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P32120700·Ti-Fix OLIF Spacer 32 x 12 x 7 (mm) x 0 °

    HONOUR™ Spacer System

    FDA UDI
    NEXXT SPINE, LLC·00889929002810·Cervical PEEK, 6°, 12mm W x 12mm D x 7mm H

    SYRINGE 5ML S/T

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 18, 2021

    HONOUR™ Spacer System

    FDA UDI
    NEXXT SPINE, LLC·00889929002827·Cervical PEEK, 0°, 12mm W x 12mm D x 7mm H

    CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORALLITE COMPREHENSIVE EXAM TRAY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·October 23, 2008

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011

    DIMENSION RXL MAX WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·July 8, 2013

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017