BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    ENDOBUTTON

    FDA UDI
    Smith & Nephew, Inc.·03596010496997·35 MM ENDOBUTTON CL BTB

    Dilator, Vascular, Memory 20cm 2.0mm alu-handle YELLOW

    FDA UDI
    Geister Medizintechnik GmbH·04057034046227·Dilator, Vascular, Memory 20cm 2...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706336·Miller Rake Retractor 5-1/4" (13.1cm), 9 sharp ...

    ANALYTICHEM USA, INC.

    FDA registration
    ANALYTICHEM USA, INC.·13 products·🇺🇸 United States

    Sapphire II Pro

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942020·Balloon Dilatation Catheter

    V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Other ·DEXCOM, INC.·Product code MDS·August 2, 2011

    ECHELON 60 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008

    FINELINE II

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

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    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

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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