BEUDAMED
    24 results · 27ms · Sources: EU EUDAMED, US FDA

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    MACROPRO GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040043905·Elevator #35

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005181·1 gal HC Liquid

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005997·ISOLA SPINE SYSTEM TWISTER CONNECTOR 4.75mm

    intellijoint KNEE®

    FDA UDI
    Intellijoint Surgical Inc·00628184005187·Bone Pin, 3.2 mm x 90 mm

    GeneXpert Dx System

    FDA UDI
    CEPHEID·07332940001452·Additional Catalog numbers: 900-0518-1, 900-051...

    Non-Telescopic PenEvac

    FDA UDI
    I.C. MEDICAL, INC.·00817688020585·

    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

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

    BRANEMARK NOVUM

    FDA 510(k)
    FDA Class 2 ·Dental

    UNK_NAVISTAR THERMOCOOL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 9, 2022

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 12, 2013

    TRIAGE CARDIAC PANEL 25 TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·February 1, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·February 15, 2008

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    BrightView SPECT (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

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017