BEUDAMED
    24 results · 26ms · 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 ×

    TRAUS SIP20

    FDA 510(k)
    FDA Class 1 ·Dental

    AGXO

    FDA UDI
    Oticon A/S·05707131350701·G400 S, BTE PP 13 2.4G 105 C092 AGXO

    RAPID INFILTRATION II

    FDA UDI
    The Wells Johnson Company·B458201292000·Cannula, Rapid Infiltration II, specify length,...

    LSN

    FDA 510(k)
    FDA Class 2 ·Radiology

    Impla-NX (Model: ISE-270M)

    FDA 510(k)
    FDA Class 1 ·Dental

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 3, 2022

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 20, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

    INFUSO.R.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SPEEDBAND SUPERVIEW SUPER 7?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FHN·July 2, 2013

    BEAD BLOCK

    FDA Adverse Event
    Death ·BIOCOMPATIBLES UK LTD·Product code HCG·February 25, 2016

    LC BEAD

    FDA Adverse Event
    Death ·BIOCOMPATIBLES UK LTD·Product code HCG·February 26, 2016

    TI LOW PROFILE NEURO DOUBLE Y-PLATE 6 HOLES 18MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code JEY·September 9, 2020

    TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code JEY·September 10, 2020

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·September 10, 2020

    UNK - SCREWS: TRAUMA

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·September 10, 2020

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·August 23, 2018

    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