BEUDAMED
    17 results · 37ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705000937·Mini Anchor Threader Tab

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707173·Fomon Nasal Rasp 8" (20cm), #7/8, fine / medium...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039655·DEPTH STOP FOR sEEG ANCHOR BOLT DRIVER, FOR 2.4...

    Bicuspid Laminated Mesh

    FDA UDI
    TP ORTHODONTICS INC·00192029049594·Bonding Base

    SYNGO.CT CARDIAC FUNCTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISPOSABLE STORAGE CAP

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012