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

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    Smith & Nephew Intramedullary Nail Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010595775·3.5 MM CONCAVE, FULL RADIUS, ...

    CENTRIMAG RETURN CANNULA KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA Adverse Event
    Malfunction ·SMITH NEPHEW INC.·Product code HAB·January 30, 2024

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 29, 2014

    PERI-LOC 3.5MM T20 LOCK SCREW 42MM S-T

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWC·August 13, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    BD¿ ENTERAL SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 8, 2023

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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