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

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    MODIFICATION TO PROVIDENT HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092179352·Biomet 3i Certain®-compatible 4.1mm Scan Body K...

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174051·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174151·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008705·PedFuse Respond, CNL, 9.0mm x 45mm

    SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYRINGE 1ML LL W/O DN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 20, 2020

    ALTRX +4 10D 32IDX50OD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 13, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Death ·INVACARE CORP.·Product code FNL·February 21, 2011

    MAVERICK2 MONORAIL PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·February 19, 2008

    MELODY TRANSCATHER PULMONARY

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code NPV·March 23, 2015

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 2, 2018

    TRULIANT PS CEM FEM PS CEM LEFT SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 30, 2023

    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

    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