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

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    MIE SCINTRON GAMMA CAMERA SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Palatal Expander2 Appliance

    FDA UDI
    Ortho Organizers, Inc.·00190707064402·Nitanium® Palatal Expander2 Appliance (40mm)

    OCCU-FLO PUNCTUM PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LIO·August 22, 2018

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 30, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

    PROSPERA PD -103 BRACHYTHERAPY SOURCE

    FDA Adverse Event
    Injury ·NORTH AMERICAN SCIENTIFIC·Product code KXK·July 24, 2008

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    NITANIUM PALATAL EXPANDER

    FDA Adverse Event
    Malfunction ·ORTHO ORGANIZERS, INC.·Product code DYJ·April 5, 2007

    TRUESPAN 24 DEGREE PEEK

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code MBI·February 19, 2025

    TRUESPAN 24 DEGREE PEEK

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code MBI·February 19, 2025

    TRUESPAN 24 DEGREE PEEK

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code MBI·February 19, 2025

    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·November 20, 2013

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021