99 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VINYL PATIENT EXAMINATION GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981360·anteriors; shade D2; mould BS2
PATHFAST CK-MB-II, PATHFAST MYO-II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ON-Q* Pump with Bolus
FDA 510(k)
FDA Class 2
·General Hospital
VANGUARD ARCOM SERIES-A PATELLA
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·May 10, 2018
UMBILICAL CATHETER
FDA Adverse Event
Malfunction
·VYGON·Product code FOS·February 17, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 27, 2013
ECHELON 45 ENDOPATH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012
AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code LJS·January 9, 2012