BEUDAMED
    32 results · 21ms · Sources: EU EUDAMED, US FDA

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    IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BONE RASPATORY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896081468·BONE RASPATORY DOUBLE ENDED TIPS #772

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450178416·

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981056414·Plate - 4 Level - 88 mm

    Cellvizio® 100 series (488nm)

    FDA UDI
    MAUNA KEA TECHNOLOGIES·03760187911007·

    VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ATAC PAK AST REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 7, 2022

    Cellvizio® 100 series (488nm)

    FDA UDI
    MAUNA KEA TECHNOLOGIES·00827002472716·

    VALIANT CAPTIVIA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 8, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 13, 2011

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021