BEUDAMED
    32 results · 47ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    FDA Recall
    Open, Classified ·AMTEC SALES Inc·Product code ITX·August 12, 2021

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    FDA Enforcement
    Class I ·Ongoing·AMTEC SALES Inc·September 29, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021