Flexicare Medical, Ltd.

• CCK — Anesthesiology2 devices
• BTR — Anesthesiology1 device
• BYF — Anesthesiology1 device
• BZE — Anesthesiology1 device
• CAH — Anesthesiology1 device
• EZD — Gastroenterology, Urology1 device

• Z-0497-2021 — 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 customersClass I·Terminated·2020-09-22
• Z-0801-2020 — BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 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.Class II·Terminated·2019-11-27
• Z-0804-2020 — 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)181002320Class II·Terminated·2019-11-27
• Z-0803-2020 — 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.Class II·Terminated·2019-11-27
• Z-0802-2020 — BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 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.Class II·Terminated·2019-11-27

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K150900 — Flexicare Heated Wire Breathing SystemsCode BZE·2015-05-15
• K140473 — DUALGUARDCode CCK·2014-04-10
• K140113 — O2 NASAL CANNULA WITH CO2 MONITORINGCode CCK·2014-03-06
• K132619 — CLASSIC INTERMITTENT CATHETERCode EZD·2013-10-11
• K092218 — FLEXICARE BREATHING FILTERSCode CAH·2009-10-06
• K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBESCode BTR·2009-06-17
• K951652 — VENTIMASK MK IVCode BYF·1995-04-27