BEUDAMED
    14 results · 22ms · 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 ×

    HIT Clear Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010605030·MTO BULLET ACL ECCENTRIC 9MM

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383514491·"An absorbent paper points is an endodontic pap...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight

    ELECSYS PROLACTIN II CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MAGELLAN-2200, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·October 23, 2008

    UNK SALINE IMPLANT

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURER·Product code FWM·August 10, 2011

    CURRENT ACCEL VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 12, 2025

    BD MICROLANCE ¿ 3 NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 7, 2022

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015