BEUDAMED
    36 results · 25ms · Sources: EU EUDAMED, US FDA

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    S-SCAN, MODEL 9800020010

    FDA 510(k)
    FDA Class 2 ·Radiology

    thixoflex M

    FDA UDI
    ZHERMACK SPA·EZHIC1006700·Condensation Silicone impression material

    U.S. ARMY-NAVY RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049406·U.S. ARMY-NAVY RETRACTOR

    DEBAKEY LIGATURE CARRIER CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006700·DEBAKEY LIGATURE CARRIER CLAMP PARTIALLY SERRAT...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450177624·

    REMSTAR PRO C-FLEX+

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    PICCOLO CHLORIDE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NITRILE EXAM GLOVE, POWDER FREE, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    TRIAGE CARDIAC PROFILER KIT

    FDA Adverse Event
    ALERE SAN DIEGO, INC.·Product code MMI·May 11, 2011

    MITYONE MUSHROOM CUP BOX OF 12

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code HDB·June 25, 2024

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 14, 2019

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 22, 2023

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    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