BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MONDRIAN ALIF Cage with Supplementary Fixation Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Data-Cyte Plus 2 0.8%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137341459·Reagent Red Blood Cells panel used for identifi...

    FLEXCERA BASE

    FDA Adverse Event
    Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

    DATA-CYTE PLUS 2 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·September 3, 2024

    CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

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

    SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

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

    DATA-CYTE PLUS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·January 10, 2025

    DATA-CYTE PLUS 2 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·September 11, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    SEARCH-CYTE PLUS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·May 19, 2026

    UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER TRAUMA SELZACH·Product code HTY·October 30, 2014

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 16, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·April 29, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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