79 results
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14ms
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Sources: EU EUDAMED, US FDA
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·March 2, 2016
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·December 19, 2012
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed.
FDA Enforcement
Class II
·Terminated·Leica Biosystems Newcastle Ltd.·January 22, 2014
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·January 23, 2019
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