BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    OviTex PRS (Long Term Resorbable)

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

    NA

    FDA UDI
    Synthes GmbH·10886982153678·4.5MM CORTEX SCREW 70MM

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114086·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1201-1 L...

    HONOUR™ Spacer System

    FDA UDI
    NEXXT SPINE, LLC·00889929003022·Cervical PEEK, 6°, 14mm W x 12mm D x 7mm H

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586017827·

    HONOUR™ Spacer System

    FDA UDI
    NEXXT SPINE, LLC·00889929003039·Cervical PEEK, 0°, 12x14x7

    HONOUR™ Spacer System

    FDA UDI
    NEXXT SPINE, LLC·00889929003046·Cervical PEEK, 10°, 14mm W x 12mm D x 7mm H

    C-CURVE Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPOCH HIP PROSTHESIS, MODEL 4075 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    DELTEC® PORT-A-CATH®

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code LJT·November 7, 2017

    FMP HIP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code LPH·August 2, 2011

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·August 14, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    BD 5ML SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 27, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·February 9, 2018

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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