BEUDAMED
    20 results · 35ms · Sources: EU EUDAMED, US FDA

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    HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092118344·3i Certain 4.1mm x 4.5mm Non-Engaging Titanium ...

    Preat

    FDA UDI
    Preat Corporation·00842092170892·Biomet 3i Certain®-compatible 4.1mm X 4.5mm Non...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756656290·2 PORT RT ON HP MANIFOLD 25C

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 13, 2018

    HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

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

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 17, 2015

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 31, 2014

    MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST

    FDA Adverse Event
    Malfunction ·MAXIM BIOMEDICAL, INC.·Product code QKP·September 8, 2022

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 11, 2013

    INSYNC III

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code DXY·February 25, 2011

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·February 19, 2008

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWE·September 9, 2021

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 15, 2018

    BD LUER-LOK 3ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 19, 2019

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024