697 results
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Sources: EU EUDAMED, US FDA
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Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 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
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF 000292, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
FDA Recall
Terminated
·C R Bard Inc·Product code KGC·January 20, 2009
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·September 23, 2008
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
FDA Recall
Terminated
·C R Bard Inc·Product code KNT·September 23, 2008
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·February 17, 2016
Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·February 17, 2016
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code HRX·July 27, 2018
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019
1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·October 1, 2019
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code FTL·September 4, 2012
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007
Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007
Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·April 8, 2010
Davol Salute Laproscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007
Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GWD·July 16, 2007
Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014