29 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 25, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 25, 2021
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·November 29, 2017
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021