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

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    3MP Monochrome Digital Mammography LCD Monitor MS-S300

    FDA 510(k)
    FDA Class 2 ·Radiology

    KeyPrint

    FDA UDI
    Keystone Industries·H66842001611·KeySplint Soft Clear Resin, 0.5kg

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·04026704417599·LAMINECTOMY WEDGES STERILE 3/4"X3/8"

    4285 SLIDE VLV CONTROL

    FDA UDI
    HANS RUDOLPH, INC.·00817136022215·FOOT SWITCH ASSY MOMENT 4285

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM

    Nanoplasty System

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222419·1st Met Inserter Draw Bar

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898306365·STD LINER 36-66/70

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

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

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC INC·Product code LKK·December 11, 2001

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC INC·Product code LKK·December 11, 2001

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    CAPSURE SP NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 24, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013

    ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    ARIES SARS-COV-2 EUA

    FDA Adverse Event
    Malfunction ·LUMINEX CORPORATION·Product code QJR·October 27, 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