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    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 Recall
    Terminated ·ASI Medical, Inc.·Product code EIA·November 5, 2013

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Recall
    Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

    FDA Enforcement
    Class II ·Terminated·Zeus Scientific, Inc.·September 18, 2019

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Enforcement
    Class II ·Terminated·Gsi Group Inc·March 2, 2016

    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

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Enforcement
    Class II ·Terminated·Lsi Medience Corporation·November 30, 2016

    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·August 18, 2021

    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·July 14, 2021

    FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·July 14, 2021

    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·May 2, 2018

    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

    FDA Recall
    Terminated ·Zeus Scientific, Inc.·Product code N/A·July 22, 2019

    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.

    FDA Enforcement
    Class II ·Terminated·Restoration Robotics·November 27, 2013

    I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·January 2, 2019

    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·June 30, 2021

    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020

    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020

    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020