BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    BTL-785W

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

    FRESENIUS 2008T HEMODIALYSIS MACHINE

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

    Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

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

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 5, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM-WAIST PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·January 9, 2018

    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

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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

    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