BEUDAMED
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    Critical Care Suite with Endotracheal Tube Positing AI algorithm

    FDA 510(k)
    FDA Class 2 ·Radiology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111825·HALO, 1203-5 VEST SMALL, LAMBSWOOL LINER, 1211-...

    PERFSCAPE V2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

    FDA 510(k)
    FDA Unclassified ·Unknown

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 29, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 15, 2011

    INGENIO

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

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023

    RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 12, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 15, 2023

    RAD-97 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 5, 2023

    BD PHASEAL¿ LUER-LOCK INJECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FPA·May 10, 2023

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024

    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

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026