BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    ComPAS2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RUSCH MEMORY BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 1, 2023

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 30, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 24, 2024

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 7, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 17, 2011

    SJM REGENT HEART VALVE W/ FLEX CUFF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO INC·Product code LWQ·July 3, 2013

    RELION INSULIN SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 19, 2023

    RELION INSULIN SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 19, 2023

    ALIZE II CUP HA 56

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 29, 2020

    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017