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FDA 510(k) & PMA Approved Dispositivos — 12 products

Total de dispositivos12
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K262215 Profoject™ Safety Sliding Blood Collection SetJKA2026-09-25 Ver
510(k) K261372 Profoject™ LOR SyringeCAZ2026-09-25 Ver
510(k) K261829 Profoject™ Dual-Safety Pen NeedlesFMI2026-07-29 Ver
510(k) K260739 Profoject™ Pen Needles (Model A; Model B)FMI2026-07-15 Ver
510(k) K260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleFMF2026-06-12 Ver
510(k) K260855 Profoject™ Safety Pen NeedlesFMI2026-06-10 Ver
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 Ver
510(k) K253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeFMF2026-02-23 Ver
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 Ver
510(k) K252631 Profoject™ Disposable NeedleFMI2025-10-16 Ver
510(k) K252033 Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleFMF2025-07-25 Ver
510(k) K251585 Profoject™ Enteral Feeding SyringePNR2025-07-18 Ver
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