BEUDAMED
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    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·August 29, 2016

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L

    FDA Recall
    Terminated ·Bard Access Systems·Product code LJS·August 8, 2014

    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

    FDA Recall
    Terminated ·Arrow International Inc·Product code OBJ·January 9, 2015

    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·August 29, 2016

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·August 29, 2016

    GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·July 14, 2010

    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018

    BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018

    BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018

    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018

    Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018

    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016

    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland), Inc.·Product code IYE·October 5, 2012

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 12, 2016