BEUDAMED
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    PathBuilder Transseptal Guiding Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584114797·CZ9 MNR, 2.4G NFM MAC CORAL 9 GPL

    WEGO-PGA Absorbable Surgical Suture With Needle

    FDA UDI
    Foosin Medical Supplies Inc., Ltd.·06941813601036·

    WEGO-PGA Absorbable Surgical Suture With Needle

    FDA UDI
    Foosin Medical Supplies Inc., Ltd.·06941813609032·

    200 MICRON TFL SINGLE USE FIBER

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·August 31, 2022

    OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIPSONIX(R) SYSTEM MODEL 2

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

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code OAE·October 27, 2015

    SOLTIVE PRO SUPERPULSED LASER SYSTEM

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·August 31, 2022

    DUR MAR NEUT LINER 28IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 24, 2008

    NEXGEN STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 11, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    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

    DRX Revolution Mobile X-Ray System

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