Company · SG
CMT Health PTE., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (10 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2026 | K262242 | Profoject Safe Push Button Blood Collection Sets CMT Health PTE., Ltd., SG | JKA |
| Sep 25, 2026 | K262215 | Profoject Safety Sliding Blood Collection Set CMT Health PTE., Ltd., SG | JKA |
| Sep 25, 2026 | K261372 | Profoject LOR Syringe CMT Health PTE., Ltd., SG | CAZ |
| Jul 29, 2026 | K261829 | Profoject Dual-Safety Pen Needles CMT Health PTE., Ltd., SG | FMI |
| Jul 15, 2026 | K260739 | Profoject Pen Needles (Model A; Model B) CMT Health PTE., Ltd., SG | FMI |
| Jun 12, 2026 | K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle CMT Health PTE., Ltd., SG | FMF |
| Jun 10, 2026 | K260855 | Profoject Safety Pen Needles CMT Health PTE., Ltd., SG | FMI |
| Apr 8, 2026 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject EN CMT Health PTE., Ltd., SG | PNR |
| Feb 23, 2026 | K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe CMT Health PTE., Ltd., SG | FMF |
| Feb 19, 2026 | K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoje CMT Health PTE., Ltd., SG | QNQ |
| Oct 16, 2025 | K252631 | Profoject Disposable Needle CMT Health PTE., Ltd., SG | FMI |
| Jul 25, 2025 | K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle CMT Health PTE., Ltd., SG | FMF |
| Jul 18, 2025 | K251585 | Profoject Enteral Feeding Syringe CMT Health PTE., Ltd., SG | PNR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||