Medical Device Manufacturer · SG , Singapore

CMT Health PTE., Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2025

Recent clearances: Profoject™ LOR Syringe, Profoject™ Safety Sliding Blood Collection Set, Profoject™ Dual-Safety Pen Needles

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - CMT Health PTE., Ltd. General Hospital ✕

9 devices

1-9 of 9

Cleared Sep 25, 2026

Profoject™ Safety Sliding Blood Collection Set

General Hospital · 87d

Cleared Jul 29, 2026

Profoject™ Dual-Safety Pen Needles

General Hospital · 57d

Cleared Jul 15, 2026

Profoject™ Pen Needles (Model A

General Hospital · 131d

Cleared Jun 12, 2026

Profoject™ Safety Needle

General Hospital · 115d

Cleared Jun 10, 2026

Profoject™ Safety Pen Needles

General Hospital · 86d

Cleared Feb 23, 2026

Profoject™ Insulin Syringes

General Hospital · 154d

Cleared Feb 19, 2026

Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe

General Hospital · 168d

Cleared Oct 16, 2025

Profoject™ Disposable Needle

General Hospital · 57d

Cleared Jul 25, 2025

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle

General Hospital · 25d