BEUDAMED
    38 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023

    Burlington Medical, Demi Half Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt Blockers.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Protective Sleeves.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Half Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Blockers.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Thyroid Shield.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Wrap Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Leg Wraps.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019