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

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    Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

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

    ELITE

    FDA UDI
    Smith & Nephew, Inc.·03596010566591·ELITE PASS SUTURE SHUTTLE W/O RATCHET

    640 - Certi-Gauze Compress - 24"x 72" - 1/Unit

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588110219·640 - Certi-Gauze Compress - 24"x 72" - 1/Unit

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551110460·HALO, 1203-5 VEST PED0, ACRYLIC LINER, 1211-1 S...

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    EASYPOINT

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023

    LASER 20

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

    CUBESCAN / BIOCON-700

    FDA 510(k)
    FDA Class 2 ·Radiology

    COROX OTW-S 75-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code OJX·October 29, 2014

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 13, 2011

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013

    DEKA MOTUS AZ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024

    CORTRAK ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Injury ·HALYARD HEALTH·Product code KNT·May 4, 2018

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024

    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

    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

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    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