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

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    TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00274401·

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020160·Endo Carry-On Procedure Kit

    Extraoral Cassette with LANEX Medium Screens

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971002747·Extraoral Cass w/ LANEX MED SCR 15x30cm

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20027400·3.0mm Cannulated Screw, Self-Drilling, Long Thr...

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2002740·3.0mm, Cannulated Screw, Self Drilling, Long T...

    KSEA MONOPOLAR VAPORIZATION ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2011

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008

    DIST HUM LAT L 9H 85MM ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRS·December 22, 2022

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRS·December 22, 2022

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 14, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 14, 2024

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

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

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