98 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
Philips C9-5EC Transducer.
FDA Enforcement
Class II
·Ongoing·Philips Ultrasound, Inc·July 9, 2025
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
FDA Enforcement
Class II
·Terminated·GE Healthcare·March 25, 2015
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA Enforcement
Class II
·Ongoing·Adept Medical Ltd·January 29, 2025
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Enforcement
Class II
·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024
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
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