63 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFIED NEURO SURGERY NIBBLING FORCEPS
FDA 510(k)
FDA Class 1
·Neurology
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048489·3 hole flanges
MODIFIED BLOOD CELL COUNTING & LYSING
FDA 510(k)
FDA Class 1
·Hematology
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
FDA 510(k)
FDA Class 2
·Ophthalmic
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 28, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
I-STAT 1 ANALYZER - IMMUNO READY
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JJE·August 26, 2010
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.
FDA Recall
Terminated
·AngioDynamics Inc.·Product code OEZ·November 3, 2015
NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
FDA Recall
Terminated
·AngioDynamics Inc.·Product code OEZ·November 3, 2015
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
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DYB·September 28, 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
NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
FDA Recall
Terminated
·AngioDynamics Inc.·Product code OEZ·November 3, 2015
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
FDA Recall
Terminated
·AngioDynamics Inc.·Product code OEZ·November 3, 2015
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV 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. Non-valve lumens are indicated for central venous pressure monitoring
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV 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. Non-valve lumens are indicated for central venous pressure monitoring
FDA Recall
Terminated
·Navilyst Medical, Inc., an AngioDyamics Company·Product code LJS·March 14, 2016