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

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    Physica system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint

    FDA UDI
    HEMOSTASIS, LLC·00858439001248·PosiSep devices are patient-comfortable sponges...

    NA

    FDA UDI
    Smith & Nephew, Inc.·23596010513674·T-MAX SQUARE RALL CLAMPS 2 PER BOX

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180120747·5 MM DIA., 45 CM INSULATED J-HOOK TIP ELECTRODE...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154629350·PLATE,SAGITTAL SPLIT,14MM BAR

    BIOCERAMIC ORBITAL IMPLANT, ORBTEX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 31, 2019

    ESSURE

    FDA Adverse Event
    Malfunction ·BAYER PHARMA AG·Product code HHS·October 29, 2014

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 9, 2015

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025