BEUDAMED
    30 results · 29ms · Sources: EU EUDAMED, US FDA

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    PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

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

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741102868·Catheter Placement Kit

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502201·TeWa 5CB-Type 3025 Speed Pak (s): uncoated acup...

    Penile Clamp

    FDA UDI
    C. R. Bard, Inc.·00801741049002·Penile Clamp

    GeneXpert Dx System

    FDA UDI
    CEPHEID·07332940004125·XPERT, GENEXPERT DX SYSTEM

    VBeam Prima DCD Delivery System

    FDA UDI
    Candela Corporation·00817495023014·Delivery System Assembly

    BREAST IMPLANT, 230 CC

    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·January 21, 1994

    MENICON Z

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENICON SF-P

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964106484·Endo Carry-On Procedure Kit

    EVIS EXERA II COLONOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDF·October 3, 2024

    QUALITY ELECTRODYNAMICS

    FDA Adverse Event
    Malfunction ·QUALITY ELECTRODYNAMICS, LLC·Product code MOS·August 30, 2019

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 12, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 24, 2011

    NOVASURWE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·CYTYC SURGICAL PRODUCTS·Product code MNB·February 21, 2008

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

    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