BEUDAMED
    16 results · 23ms · 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.
    Filters Regulation: Us FDA ×

    LUXEN CL Dental Liquid

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584114483·CO7 B 105, 2.4G NFM MSIL CAPTO 7 GPL

    BD SYRINGE LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 27, 2017

    BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 26, 2024

    ALTOMEC ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Surgical Face Mask

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

    CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 16, 2023

    CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 16, 2023

    CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 16, 2023

    CERTAIN¿ UCLA CASTABLE NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. TI SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 16, 2023

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·October 27, 2008

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·August 10, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021