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

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    VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247102·No-Profile Interbody, 35mm x 27mm x 16mm, 30 Deg

    AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANGE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

    ALLEN CONTOUR WINGSETS

    FDA Adverse Event
    Injury ·ALLEN MEDICAL SYSTEMS·Product code FWZ·October 24, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    ACUITY

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

    MEDTRONIC LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·April 3, 2025

    ONCOLOGY SALVAGE SYSTEM - NON-MOD PROX TIB 5CM 9X150

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017

    FINN KNEE PROSTHESIS - FEMORAL BUSHING SET OF 2

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    ONCOLOGY SALVAGE SYSTEM - REINFORCED YOKE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017

    FINN KNEE PROSTHESIS - LOCK PIN

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    FINN KNEE PROSTHESIS - TIBIAL BUSHING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    ONCOLOGY SALVAGE SYSTEM- TIBIAL POLY BEARING 12MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 5, 2017

    FINN KNEE PROSTHESIS - AXLE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·March 31, 2017

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·July 15, 2020

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 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