BEUDAMED
    15 results · 30ms · 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 ×

    Catalyst+, Catalyst+ HD

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006642·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 8.0mm

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707183721·Accufit Molar Bands Lower Left First Molar 43 1/2

    LAHEY-SWEET HEMOSTATIC FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060890·LAHEY-SWEET HEMOSTATIC FORCEPS RIGHT ANGLED LON...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252133742·INTERNAL MIDFACE DISTRACTOR, 35MM

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 28, 2024

    WOUND PROTECTOR/RETRACTOR

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

    AMEDA PLATINUM BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·August 17, 2016

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    COLLEAGUE PRE P1.7

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

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·July 1, 2013

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021