BEUDAMED
    64 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    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 Enforcement
    Class II ·Terminated·Westone Laboratories, Inc.·August 1, 2012

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

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

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

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 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 Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    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 Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    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 Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    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 Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·June 12, 2019