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    4DMEDICAL LIMITED

    FDA registration
    4DMEDICAL LIMITED·4 products·🇦🇺 Australia

    CT LVAS

    FDA UDI
    4DMEDICAL LIMITED·19356870000021·CT LVAS (CT:V) software is a non-invasive image...

    XV Lung Ventilation Analysis Software

    FDA UDI
    4DMEDICAL LIMITED·19356870000014·The XV Lung Ventilation Analysis Software is a ...

    CT:VQ

    FDA UDI
    4DMEDICAL LIMITED·01935687000038·CT:VQ software is a non-invasive image post-pro...

    CT:VQ

    FDA UDI
    4DMEDICAL LIMITED·19356870000038·CT:VQ software is a non-invasive image post-pro...

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·March 28, 2018

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

    BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended 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 ·Navilyst Medical, Inc·Product code LJS·August 25, 2014

    BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: 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 and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051 H96560M0367061 H96560M05019111 H96560M0501981 H96560M1201961 H96560M1201971 H96560M12202101 H96560M12202111 H96560M12202121 H96560M1303151 H96560M1303171 H96560M1303191 H96560M13184101 H96560M13184111 H96560M1318491 H96560M1401411 H96560M1401421 H96560M1401431 H96560M1401441 H96560M1406061 H96560M1406071 H96560M1633931 H96560M1803441 H96560M1803451 H96560M18157111 H96560M18157121 H96560M1841151 H96560M1841161 H96560M1841171 H96560M1907131 H96560M1907141 H96560M2204441 H96560M2208511 H96560M2208521 H96560M2322421 H96560M2500961 H96560M2500971 H96560M610115911 H96560M610901011 H96560M611025121 H96560M611025131 H96560M611052821 H96560M611056021 H96560M611056031 H96560M611095821 H96560M611095831 H965PKM030667S1 H965PKM120451S1 H965PKM1220226S1 H965PKM1300011S1 H965PKM1303119S1 H965PKM131935S1 H965PKM150124S1 H965PKM150125S1 H965PKM150127S1 H965PKM220851S1 H965PKM220854S1 H965PKM3092662S1 H965PKM61040701S1 H965PKM61066141S1 H965PKM61095321S1 H965PKM61095324S1 Cat. No. 60M0116210 60M011629 60M013353 60M013421 60M019881 60M022474 60M022475 60M033562 60M036704 60M036705 60M036706 60M0501911 60M050198 60M120196 60M120197 60M1220210 60M1220211 60M1220212 60M130315 60M130317 60M130319 60M1318410 60M1318411 60M131849 60M140141 60M140142 60M140143 60M140144 60M140606 60M140607 60M163393 60M180344 60M180345 60M1815711 60M1815712 60M184115 60M184116 60M184117 60M190713 60M190714 60M220444 60M220851 60M220852 60M232242 60M250096 60M250097 60M61011591 60M61090101 60M61102512 60M61102513 60M61105282 60M61105602 60M61105603 60M61109582 60M61109583 PKM030667S PKM120451S PKM1220226S PKM1300011S PKM1303119S PKM131935S PKM150124S PKM150125S PKM150127S PKM220851S PKM220854S PKM3092662S PKM61040701S PKM61066141S PKM61095321S PKM61095324S

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code LJS·May 4, 2020

    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: 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 and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965750231 H965750241 H965750315 H965750315-NP H965750325 H965750335 H965750335-NP H965750345 H965750355 H965750355-NP H965750365 H965750375 H965750385 H965750415 H965750425 H965750441 H965750451 H965750471 H965750481 H965750491 H965750501 H965750521 H965750531 H965750541 H965750551 H965750561 H965750571 H965750581 H965750591 H965750601 H965750611 H965750621 H965750631 H965750651 H965750661 H965750671 H965750681 H965750691 H965750701 Cat. No. 75-001 75-003 75-012 75-013 75-014 75-015 75-016 75-017 75-018 75-019 75-021 75-022 75-023 75-024 75-031 75-032 75-033 75-034 75-035 75-036 75-037 75-038 75-041 75-042 75-044 75-045 75-047 75-048 75-049 75-050 75-052 75-053 75-054 75-055 75-056 75-057 75-058 75-059 75-060 75-061 75-062 75-063 75-065 75-066 75-067 75-068 75-069 75-070

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 24, 2020

    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: 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 and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965750231 H965750241 H965750315 H965750315-NP H965750325 H965750335 H965750335-NP H965750345 H965750355 H965750355-NP H965750365 H965750375 H965750385 H965750415 H965750425 H965750441 H965750451 H965750471 H965750481 H965750491 H965750501 H965750521 H965750531 H965750541 H965750551 H965750561 H965750571 H965750581 H965750591 H965750601 H965750611 H965750621 H965750631 H965750651 H965750661 H965750671 H965750681 H965750691 H965750701 Cat. No. 75-001 75-003 75-012 75-013 75-014 75-015 75-016 75-017 75-018 75-019 75-021 75-022 75-023 75-024 75-031 75-032 75-033 75-034 75-035 75-036 75-037 75-038 75-041 75-042 75-044 75-045 75-047 75-048 75-049 75-050 75-052 75-053 75-054 75-055 75-056 75-057 75-058 75-059 75-060 75-061 75-062 75-063 75-065 75-066 75-067 75-068 75-069 75-070

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code LJS·May 4, 2020