BEUDAMED
    575 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

    FDA Enforcement
    Class I ·Ongoing·Lusys Laboratories, Inc.·March 16, 2022

    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

    FDA Enforcement
    Class I ·Ongoing·Lusys Laboratories, Inc.·March 16, 2022

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

    FDA Enforcement
    Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

    Pediatric care bed; Product Designation: KayserBett IDA;

    FDA Enforcement
    Class I ·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026

    Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

    FDA Enforcement
    Class I ·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025

    Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

    FDA Enforcement
    Class I ·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025

    ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

    FDA Enforcement
    Class I ·Ongoing·National Distribution & Contracting Inc·October 20, 2021

    ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

    FDA Enforcement
    Class I ·Ongoing·National Distribution & Contracting Inc·October 20, 2021

    ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023