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

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    Dental Implantation Systems, Dental Electrical Motors

    FDA 510(k)
    FDA Class 1 ·Dental

    AUTO SUTURE STRUCTURAL BALLOON

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·March 10, 2020

    PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404

    FDA 510(k)
    FDA Class 2 ·Hematology

    ANCHORSURE

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

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 30, 2008

    REFLEX STR

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code GCJ·June 28, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

    Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 8, 2023

    SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·September 4, 2019

    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

    FDA Enforcement
    Class II ·Terminated·Theragenics Corporation·December 26, 2018

    LUMBAR PUNCTURE TRAY ADULT 18G X 3.5

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022