104 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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TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
FDA Recall
Terminated
·Verathon, Inc.·Product code IYO·August 23, 2010
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·November 20, 2013
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·October 19, 2022
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·September 1, 2022
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code ONW·August 29, 2013
SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.
FDA Recall
Terminated
·Stryker Spine·Product code MDM·May 13, 2010
FlexTrayTM Endopath Bariatric Tray, Kit Code TBW70S.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·May 21, 2003
Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·May 21, 2003
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
FDA Recall
Terminated
·Cochlear Americas Inc.·Product code MCM·June 5, 2015