BEUDAMED
    15 results · 20ms · 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 ×

    Medtronic Extended infusion set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV

    LISS

    FDA UDI
    DIAGAST·23661562105445·Low-ionic-strength phosphate buffered saline so...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180107410·5 MM DIA., 45 CM CUTTING ELECTRODE, RETRACTABLE...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327589214·3-D PLATE, OBLIQUE

    RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    UNKNOWN DEPUY STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·October 22, 2008

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 10, 2011

    ELLIPSE DR

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

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025