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Daye Heavy Flow Refill (Daye) – 510(k) Clearance Missing (2025)

Product lacks 510(k) clearance.

FDAFeb 17, 2025Nationwide• DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom

Microstream CO2 Line (Oridion Medical) – Device Usage Risk (2025)

Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

FDAFeb 17, 2025Nationwide• Oridion Medical 1987 Ltd. Har Hotzvim Industrial

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Daye Heavy Flow Refill (Daye) – 510(k) Clearance Missing (2025)

Microstream CO2 Line (Oridion Medical) – Device Usage Risk (2025)

Simethicone Oral Drops (Safecor Health) – Leakage Risk (2025)

Daye Regular Flow Refill (Daye) – 510(k) Clearance Missing (2025)

Daye Tampon Combination (Daye) – 510(k) Clearance Missing (2025)

Daye Super Tampons (Daye) – 510(k) Clearance Missing (2025)

Daye Regular Tampons (Daye) – 510(k) Clearance Missing (2025)

Daye Refill Bundle (Daye) – 510(k) Clearance Missing (2025)

Lorazepam Oral Syringe (Safecor Health) – Leakage Risk (2025)

Daye Tampon Initiation Mix (Daye) – 510(k) Clearance Missing (2025)

Daye Regular Flow Bundle (Daye) – 510(k) Clearance Missing (2025)

Daye Heavy Flow Bundle (Daye) – 510(k) Clearance Missing (2025)

Introcan Safety 3 IV Catheter (B Braun) – Valve Housing Risk (2025)

Daye Trial Box Refill (Daye) – 510(k) Clearance Missing (2025)

Ferrous Sulfate Syringe (Safecor Health) – Leakage Risk (2025)

Vitamin D Supplement (Safecor Health) – Leakage Risk (2025)

Daye Trial Tampon Box (Daye) – 510(k) Clearance Missing (2025)

Daye Super Tampons (Daye) – 510(k) Clearance Missing (2025)

Daye Super Tampons Refill (Daye) – 510(k) Clearance Missing (2025)

Daye Tampon Refill Mix (Daye) – 510(k) Clearance Missing (2025)