BEUDAMED
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    IPL Hair Removal

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

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 5, 2021

    CLEARPATH 24

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RANDOX THERAPEUTIC DRUG CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·August 15, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    ULTRAFLEX DUO HIGH FLUID CART

    FDA Adverse Event
    Malfunction ·DORNOCH·Product code JCX·August 28, 2017

    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

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    DRX Revolution Mobile X-Ray System

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