Company
Flexicare Medical (Dongguan) Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CCW | Laryngoscope, Rigid | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Single-Use Fiber Optic Laryngoscope Handle
Refs:040-310AU and 040-310U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle
REF:040-309U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle
REF:040-03-0000U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Mini with Pro Miller Blade Size 1.5,
REF:040-02-0415U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. 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 Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. 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),
040-02-0400 Open, Classified |
CCW | None listed |