BEUDAMED
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    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 4, 2014

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·April 17, 2013

    IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·June 6, 2011

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 30, 2014

    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·July 3, 2013

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·March 15, 2013

    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·May 28, 2013

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code GAM·March 12, 2019

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·April 24, 2019

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 19, 2014

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·May 14, 2014

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OCC·October 10, 2013

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OAR·February 13, 2020

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012