BEUDAMED
    25 results · 24ms · Sources: EU EUDAMED, US FDA

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    OPTRELL Mapping Catheter with TRUEref Technology

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BBL™ Mueller Hinton II Agar

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902114383·BD BBL™ Mueller Hinton II Agar, 500 g

    BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    REKA E100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BBL¿ MUELLER HINTON II AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·March 2, 2022

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JTZ·July 19, 2021

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JTZ·March 16, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 29, 2014

    BIPOLAR WORKING ELEMENT

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code GEI·August 9, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

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

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·July 22, 2022

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·July 21, 2022

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·May 21, 2022

    BD BBL MUELLER HINTON II AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JTZ·September 18, 2024

    PLATE MUELLER HINTON II AGAR 20 EA

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·June 30, 2022

    BD BBL¿ MUELLER HINTON II AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JTZ·February 20, 2025

    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 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