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

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    DiLumen Endolumenal Interventional Platform (DiLumen)

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

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    HARRISON HAND HELD ADJUSTING INSTRUMENT

    FDA 510(k)
    FDA Unclassified ·Unknown

    COMMUNIFY PACS VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CANCELLOUS

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    3.0MM CARBON FIBER ROD 75MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·July 20, 2018

    3.0MM CARBON FIBER ROD 75MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·July 20, 2018

    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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015