BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694007061·2.4mm Locking Drill Guide

    BAILEY HEMOSTATIC FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896061187·BAILEY HEMOSTATIC FORCEPS ACUTE ANGLED EXTRA FI...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102859·MONOPOLAR RF CABEL WITH 4MM DIA., MALE BANANA U...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319742815·Jansen-Middleton Septum Forceps 7-1/2" (19.1cm)...

    ACUMED

    FDA UDI
    Acumed LLC·10806378014444·2.7mm x 10.0mm Locking Cortical Screw

    ACUMED

    FDA UDI
    Acumed LLC·10806378014451·2.7mm x 10.0mm Locking Cortical Screw

    TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SONATA MICRO HYBRID COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    UNK

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code FTL·August 28, 2012

    GORE DUALMESH BIOMATERIAL

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code FTL·August 28, 2012

    BIOCOR SUPRA VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL BRASIL LTDA.·Product code LWR·October 24, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

    MECTALIF TRANSFORAMINAL CAGES TIPEEK

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021