BEUDAMED
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    AtriCure Isolator® Synergy™ Surgical Ablation System

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

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205003263·Luna Opal R Mini .018 UR4,5 D/HK (-7°T 0°A)

    NA

    FDA UDI
    Medos International Sàrl·10886705001590·Trocar Point Guide Pin 15 Inches (38cm) 2.4mm D...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551135920·HALO, 1203-5 VEST X-LARGE, ACRYLIC LINER, 1211-...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167312113110·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167322113110·

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946046330·X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE,...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946071745·X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE...

    SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING

    FDA 510(k)
    FDA Class 2 ·Radiology

    UROLOGIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 16, 2022

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·November 17, 2018

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·August 3, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·DOLOMITE AB·Product code ITJ·October 29, 2014

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·May 21, 2020

    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

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026