7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
FDA Enforcement
Class I
·Terminated·Flexicare Medical Ltd.·December 2, 2020
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025