BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    cobas Cdiff nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    B.BRAUN

    FDA UDI
    B. BRAUN MEDICAL INC.·04046964247385·Hemodialysis Administration Set

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885554011326·MTO OBTURATOR BLUNT 5.0MM

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185268·AccuFit™ Molar Band UL7 - 38.5

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039853·sEEG DEPTH DRILL GUIDE REDUCING TUBE, FOR 2.1MM...

    CONTINUUM PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER

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

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·August 8, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 23, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 29, 2026

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 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