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

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    TruAbutment DS, TruBase

    FDA 510(k)
    FDA Class 2 ·Dental

    U2 Total Knee System, XPE Tibial Insert, PS PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENTREX BIOSPONGE MPD

    FDA 510(k)
    FDA Unclassified ·Unknown

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·October 28, 2008

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 17, 2011

    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 9, 2013

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM 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