29 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Dimension Vista Assays: Enzymatic Creatine (ECRE)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·June 17, 2015
Dimension Assays: ENZYMATIC CREATININE
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·January 18, 2017
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·June 17, 2015
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 24, 2013
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 24, 2013
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 24, 2019
Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
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 Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014
Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
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 Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix" LP with Echo PS" 6 x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014