BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    CytoCore

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PROFYLE

    FDA UDI
    Stryker GmbH·04546540256188·Drill Guide F,Single Hook Plate

    Targeter

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223805·Targeter Body Right

    Navajo Tribal Utility Authority - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112632·BARRON CORNEAL PUNCH 8.0MM

    QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIVANT MEDICAL BIOPSY MARKER SYSTEM

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

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·April 4, 2025

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 1, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 24, 2019

    ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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