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

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    TRIGLYCERIDES TEST (500NM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    0800,APS1,08,N,LU,LD,IT

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153232·0800,APS1,08,N,LU,LD,IT

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

    IMAGE X-70 PLUS DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHYSICA KR TIB. LINER LEFT #5

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HRY·October 30, 2018

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code KWP·May 8, 2014

    SENSIA SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·October 22, 2012

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·August 12, 2010

    BD PLATE CAMPYLOBACTER SB 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

    MECTALIF TRANSFORAMINAL CAGES TIPEEK

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·March 17, 2011

    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·December 19, 2017

    Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DTK·September 27, 2013

    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

    FDA Recall
    Terminated ·CHENICA INC.·Product code IOR·January 18, 2013