BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Zap-X Radiosurgical System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRAUMA INTERNAL FIXATION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FIBULA COMP LOCK PLATE 10H STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

    CORONOID PLATE RT STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FQH·August 5, 2011

    MATRIX 2 360

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code HCG·October 16, 2008

    ACTIVA

    FDA Adverse Event
    Injury ·NEURO - VILLALBA·Product code MHY·July 8, 2013

    S3 SHOULDER PLATE 4 HOLE RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 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 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021