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

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    IMPROVED ENLIGHT LV

    FDA 510(k)
    FDA Class 2 ·Dental

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092131220·Biomet 3i Certain®-compatible 5.0mm 17° Multi-U...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104521·Biomet 3i Certain®-compatible 5.0mm 17° Multi-U...

    Health-Tec Aspirating Syringe

    FDA UDI
    Dental Health Products Inc·D77370018810·Health-Tec Aspirating Syringe, A-Type

    BREAST IMPLANT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FTR·April 29, 1994

    BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERFADEX SOLUTION FOR ORGAN PRESERVATION

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

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 12, 2013

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 25, 2011

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    FDA Adverse Event
    BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·February 19, 2008

    OXF ANAT BRG RT MD SIZE 4 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·March 30, 2020

    OXFORD PH3 CEMENTLESS FEM SZ M

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HRY·March 30, 2020

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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