BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Millipede 088 Access Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Synthes GmbH·10886982153562·4.5MM CORTEX SCREW 48MM

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996101073·VBR,SPACER,12X14X48,0 DEG

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113928·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 L...

    M.U.S.T. PEDICLE SCREWS SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025

    IMAGEQUBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS

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

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·January 13, 2026

    M.U.S.T. PEDICLE SCREWS SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·October 23, 2008

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 17, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OUR·October 16, 2024

    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