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

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    SYSMEX UF-100

    FDA 510(k)
    FDA Class 2 ·Hematology

    Hemoglobin Capillary Collection System (HCCS)

    FDA UDI
    BIO-RAD LABORATORIES, INC.·00847817002731·Holder for manipulating the capillaries.

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295234791·P.F.C. SIGMA TC3 BOX TRIAL SZ 4

    LCMS-8050 CL

    FDA UDI
    SHIMADZU CORPORATION·04540217400621·

    Titan Reverse Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556863688·BASEPLATE CENTRAL DRILL-S

    Titan™

    FDA UDI
    Ascension Orthopedics, Inc.·10381780467861·Baseplate Central Drill-S

    AXIOM ARISTOS FX PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISPOSABLE RESCUE BREATHING DEVICE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·August 3, 2015

    MAXGUARD ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·January 16, 2013

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·January 11, 2011

    SP2 FEM BOX TRIAL SCREW DRIVER

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code HXX·September 27, 2016

    PFC*SIGMA TC3 FE BX TRL/SZ 4

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·September 27, 2016

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    FDA Enforcement
    Class II ·Terminated·Haag-Streit USA Inc·September 26, 2012

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025