131 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
FDA Recall
Terminated
·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Recall
Terminated
·Arrow International Inc·Product code LJS·April 11, 2018
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·January 14, 2016
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·January 14, 2016
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 2, 2016
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 2, 2016
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 26, 2019
Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GJT·May 11, 2015
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 10, 2015
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Recall
Terminated
·Arrow International Inc·Product code PND·April 23, 2019
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JWH·April 19, 2022
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
FDA Recall
Terminated
·Bard Access Systems·Product code LJT·March 18, 2010
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·December 1, 2010
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·December 22, 2008