BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    Minuteful - kidney test

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706251·Obwegeser Periosteal Elevator, 7" (17,5cm), 11m...

    SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DURABOND NON-PRECIOUS CERAMIC ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    Widex

    FDA UDI
    Widex A/S·05706069691306·Widex BEYOND B-F2 (Summer gold ) 110, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069827279·WIDEX EVOKE EBB3D (Summer gold ) 110, Telecoil,...

    PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

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

    DUROM US ACETABULAR COMPONENT 48/42 H

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·July 28, 2011

    FINELINE II

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

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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