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

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    PathBuilder Transseptal Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584114780·CZ9 MNR, 2.4G NFM SABE/MAC CORAL 9 GPL

    NEEDLE 18X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·March 24, 2025

    NEEDLE 18X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·February 19, 2025

    GETINGE 800HC- SERIES STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

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

    GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·July 25, 2024

    GALILEO® EXTRACTION TOOL, CAPTURING ROD

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·April 25, 2024

    DUR MAR 10D LNR 32IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 24, 2008

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 11, 2011

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·July 27, 2023

    CARELINK CONNECT APP ANDROID

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·July 7, 2023

    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