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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NuEra Tight Family, EMS Model

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958002113·550 Micron 5X Reusable Lightguide, 150 watt, ba...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153153801·Z-PLATTE LEFT, BAR LENGTH 12MM

    36M - Navajo Tribal Utility Authority

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

    PHOENIX SFS

    FDA UDI
    Orthofix US LLC·18257200134434·9.5MM CANULATED JANUS TAP

    ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fiber K2012879 400 micron 3X reusable fiber K2011822 400 micron single use fiber Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

    FDA Enforcement
    Class II ·Terminated·Dornier Medtech America, Inc.·May 29, 2019

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 2, 2020

    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fiber K2012879 400 micron 3X reusable fiber K2011822 400 micron single use fiber Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

    FDA Recall
    Terminated ·Dornier Medtech America, Inc.·Product code GEX·April 1, 2019

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 6, 2018

    GEM II VR

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 31, 2012

    EDWARDS SAPIEN TRANSCATHETER HEAR VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·October 27, 2014

    TERUMO ADVANCED PERFUDION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 29, 2011

    DRILL 3334800 VISAO 80K HANDPIECE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 6, 2012

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·January 15, 2013

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·January 14, 2013