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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HEX tanning booth

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

    LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055332·

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231523360·Freeman Areola Marker 42mm Diameter

    Tapered Hex Driver Parallel Well

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076160·

    RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPECTRAQUATTRO PULSED LIGHT SYSTEM

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

    LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code MBI·August 15, 2019

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·April 7, 2020

    LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code DZL·November 21, 2014

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    CAPSURE FIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 7, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

    LACTOSORB SYSTEM 2.0 X 5 MM SUSPENSION PUSH SCREW2-PACK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code MBI·September 4, 2018

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 3, 2021

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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