BEUDAMED
    201 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    FDA Enforcement
    Class II ·Terminated·ASI Medical, Inc.·December 25, 2013

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·November 27, 2024

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024