BEUDAMED
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    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584114810·CZ9 MNR, 2.4G NFM MSIL/MAC CORAL 9 GPL

    Novo Surgical Inc

    FDA UDI
    NOVO SURGICAL, INC.·00842331193736·brown needle holder, convex jaws, fine serratio...

    WEGO-PGA Absorbable Surgical Suture With Needle

    FDA UDI
    Foosin Medical Supplies Inc., Ltd.·06941813601029·

    GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

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

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

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

    NEEDLE 18X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·February 3, 2025

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    P.F.C. 32MM HEAD +5MM

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·October 24, 2008

    TRILOGY ACETABULAR LONGEVITY LINER

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

    ONE TOUCH ULTRA MINI METER

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON·Product code NBW·July 5, 2013

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022

    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

    DRX Revolution Mobile X-Ray System

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