BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    Opulent TiNbN Coated Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARIAN HIGH ENERGY LINEAR ACCELERATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUROPAL, ORDER-NO.: 2101

    FDA 510(k)
    FDA Class 2 ·Dental

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·December 21, 2023

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 29, 2025

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 29, 2025

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011

    MONOCRYL PLUS SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·July 9, 2013

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023