BEUDAMED
    20 results · 38ms · 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 ×

    PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002152·External 3.5mm Ball-top Screw

    OC-Auto

    FDA UDI
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021461·Personal Use Kit OC-Auto, for San Juan, PR

    SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·January 7, 2025

    PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO SYNCHRON CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    SYRINGE 50-60ML L/L NO NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & COMPANY·Product code FMF·December 12, 2024

    SYRINGE 50-60ML L/L NO NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & COMPANY·Product code FMF·December 12, 2024

    GREENLIGHT XPS LASER SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·December 21, 2016

    GREENLIGHT XPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·April 14, 2017

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·October 2, 2014

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 9, 2013

    SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·January 6, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023

    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

    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