34 results
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6ms
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Sources: EU EUDAMED, US FDA
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Enforcement
Class II
·Terminated·Western / Scott Fetzer Company·July 2, 2014
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·July 8, 2015
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
FDA Enforcement
Class II
·Terminated·New Star Lasers, Inc.·October 12, 2016
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Enforcement
Class II
·Terminated·New Era Orthopaedics, LLc·August 15, 2018
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
FDA Enforcement
Class II
·Terminated·New Wave Endo-Surgical, Corp.·May 17, 2023
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
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