7 results
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20ms
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Sources: EU EUDAMED, US FDA
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Enforcement
Class III
·Terminated·Datascope Corporation·June 13, 2018
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 14, 2019
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
FDA Enforcement
Class II
·Terminated·Trilliant Surgical Ltd.·January 18, 2017