BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Navident

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX K1 HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 10, 2020

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·August 8, 2018

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·August 8, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025