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

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    Cervical Stand-Alone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUICKANCHOR ORTHOCORD TAPERCUT

    FDA UDI
    Medos International Sàrl·10886705002429·MINILOK QUICKANCHOR Plus (Number 2/0) Suture Po...

    Paxeon BiPolar Head

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570201938·Bipolar Head Size 28/53

    BiPolar Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215053017·

    Signature BiPolar Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004064·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161112128530·Bipolar Head size 53

    VOLTERA POWERED SUCTION PUMP

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

    SMART GLOVE STERILE NITRILE EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TENDRIL ST

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

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·July 9, 2013

    TRAVELER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·November 9, 2015

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    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

    DRX Revolution Mobile X-Ray System

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