BEUDAMED
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    Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code EQJ·January 25, 2002

    nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code KHJ·November 22, 2024

    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.

    FDA Recall
    Terminated ·Westone Laboratories, Inc.·Product code KMJ·July 13, 2012

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code GXQ·November 22, 2024

    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code OWV·November 22, 2024

    Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023