BEUDAMED
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    NFLK-2501 Portable X-ray Unit

    FDA 510(k)
    FDA Class 2 ·Radiology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113164·HALO, 1203-5 VEST XX-LARGE, COOLMAX LINER, 1211...

    ZIRPRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    MICRODOSE CATH, MODELS 90121-201, -202, -203

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

    LEVEL 1 HOTLINE LOW FLOW SYSTEMS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024

    LEVEL 1 HOTLINE LOW FLOW SYSTEMS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 23, 2024

    MICROSTAAR INJECTOR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code KYB·October 22, 2008

    4.0MM TI CANCELLOUS BONE SCREWSLF-TPNGNARIABLE A

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·August 9, 2011

    COGNIS

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

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018