BEUDAMED
    85 results · 77ms · Sources: EU EUDAMED, US FDA

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    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·December 14, 2018

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·June 7, 2019

    DABRA CATHETER

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·April 8, 2019

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·February 20, 2019

    PHAROS EXCIMER LASER SYSTEM

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC·Product code GEX·March 3, 2021

    PHAROS EXCIMER LASER SYSTEM

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC·Product code GEX·March 3, 2021

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·January 22, 2020

    PHAROS EX-308 EXCIMER LASER

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code GEX·October 8, 2015

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·July 2, 2019

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·October 25, 2019

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·October 3, 2019

    DABRA

    FDA Adverse Event
    Injury ·RA MEDICAL SYSTEMS, INC.·Product code PDU·October 3, 2019

    PHAROS EXCIMER LASER SYSTEM

    FDA Adverse Event
    Malfunction ·RA MEDICAL SYSTEMS, INC.·Product code GEX·August 21, 2019

    Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders.

    FDA Recall
    Terminated ·Ra Medical Systems, Inc.·Product code GEX·August 23, 2019

    The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

    FDA Recall
    Terminated ·Ra Medical Systems Inc·Product code PDU·February 15, 2018

    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041

    FDA Recall
    Terminated ·Ra Medical Systems, Inc.·Product code PDU·September 19, 2019

    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

    FDA Recall
    Terminated ·Ra Medical Systems, Inc.·Product code PDU·October 16, 2020

    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.

    FDA Recall
    Terminated ·Ra Medical Systems, Inc.·Product code PDU·January 23, 2020

    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

    FDA Recall
    Terminated ·Ra Medical Systems Inc·Product code GEX·June 30, 2014

    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

    FDA Recall
    Terminated ·Ra Medical Systems, Inc.·Product code PDU·July 24, 2020