BEUDAMED
    9 results · 20ms · 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 ×

    Altor Safety 4-Ply Surgical Mask (Model:62232)

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

    ST AIA-PACK DHEA-S CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HI-WAVE; POUR-PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    DELTEC COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·October 24, 2008

    UNKNOWN DEPUY CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·August 10, 2011

    QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code NCX·December 22, 2025

    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

    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