Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

CMT Health PTE., Ltd.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories4
Latest FDA decision2026-07-29
TypeNumberDevice NameCodeDateActions
510(k) K261829 Profoject™ Dual-Safety Pen NeedlesFMI2026-07-29 View
510(k) K260739 Profoject™ Pen Needles (Model A; Model B)FMI2026-07-15 View
510(k) K260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleFMF2026-06-12 View
510(k) K260855 Profoject™ Safety Pen NeedlesFMI2026-06-10 View
510(k) K253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapPNR2026-04-08 View
510(k) K253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeFMF2026-02-23 View
510(k) K252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeQNQ2026-02-19 View
510(k) K252631 Profoject™ Disposable NeedleFMI2025-10-16 View
510(k) K252033 Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleFMF2025-07-25 View
510(k) K251585 Profoject™ Enteral Feeding SyringePNR2025-07-18 View