87 results
·
15ms
·
Sources: EU EUDAMED, US FDA
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
FDA Enforcement
Class I
·Terminated·Hummingbird Med·July 13, 2016
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
FDA Enforcement
Class I
·Terminated·Hummingbird Med·June 1, 2016
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
FDA Enforcement
Class II
·Terminated·Fisher & Paykel Healthcare, Ltd.·June 5, 2013
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142
FDA Enforcement
Class II
·Terminated·Fisher & Paykel Healthcare, Ltd.·November 19, 2014
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·May 28, 2014
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
FDA Enforcement
Class II
·Terminated·AROA BIOSURGERY·November 14, 2018
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
FDA Enforcement
Class II
·Terminated·AROA BIOSURGERY·November 14, 2018
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018