BEUDAMED
    24 results · 12ms · Sources: EU EUDAMED, US FDA

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    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

    Calcium Sulfate Hemihydrate 1.0 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

    Calcium Sulfate Hemihydrate 0.5 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code DZE·February 22, 2017

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    FDA Enforcement
    Class II ·Terminated·Ace Surgical Supply Co., Inc.·April 26, 2017

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Enforcement
    Class II ·Terminated·Ace Surgical Supply Co., Inc.·May 2, 2018

    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

    FDA Recall
    Terminated ·Embeem Inc.·Product code NAE·November 9, 2006

    Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

    FDA Recall
    Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

    Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

    FDA Recall
    Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

    Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

    FDA Recall
    Terminated ·Product code NBE·July 28, 2011

    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

    FDA Recall
    Terminated ·Baxter Healthcare Corp·Product code NBE·May 12, 2016

    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

    FDA Recall
    Terminated ·Safe N Simple, LLC·Product code NAE·August 22, 2018

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    FDA Recall
    Terminated ·CellEra LLC·Product code NAE·September 1, 2016

    Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.

    FDA Recall
    Terminated ·Baxter Bioscience·Product code NBE·January 14, 2010

    Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015

    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

    FDA Recall
    Terminated ·Mallinckrodt Manufacturing LLC·Product code NBE·October 17, 2014