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NeilMed Pharmaceuticals Inc.

United States·US-MF-000025412

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
NeilMed Sinus Rinse	NeilMed Sinus Rinse Kit 60 Premixed Sachets	FDA UDI	Class I	Active
NeilMed Sinus Rinse Refill Box	Hypertonic, 70 Premixed Packets	EUDAMEDFDA UDI	Class I	Active
NeilMed Sinus Rinse	Pediatric, 120 Premixed Sachets	EUDAMEDFDA UDI	Class I	Active
Sinus Rinse Kit	Isotonic, 10ct Packets/Sachets	FDA UDI	Class I	Active
NeilMed Nasogel	Nasogel Tube	FDA UDI	Class I	Active
NeilMed Wound Wash	WoundWash	FDA UDI	U	Active
NeilMed Sinus Rinse	Pediatric, 60 Premixed Sachets	FDA UDI	Class I	Active
NeilMed Sinus Rinse Refill Box	Isotonic, 50ct Packets/Sachets	EUDAMEDFDA UDI	Class I	Active
NeilMed Nasogel	Nasogel Spray	FDA UDI	Class I	Active
NeilMed Sinus Rinse Kit	Pediatric, 30ct Packets/Sachets	FDA UDI	Class I	Active
NeilMed Neilcleanse Piercing Aftercare Fine Mist	6095ST-FRN-INT	EUDAMED	Class IIa	Active
NeilMed NasoGel Spray	5003IFU-GSP-FRN	EUDAMED	Class I	Active
NeilMed Sinus Rinse Kids Kit with 30 Premixed Sachets	5003IFU-PED-FRN	EUDAMED	Class I	Active
NeilMed Sinus Rinse Kit with 60 Premixed Sachets	5003IFU-ADU-FRN	EUDAMED	Class I	Active
NeilMed Sinus Rinse Kids 60 Premixed Sachets	5003IFU-PED-FRN	EUDAMED	Class I	Active
Woundwash Saline Spray	K123910	FDA 510(k)	U	Active
NeilMed PediaMist	6029ST-FRN-INT	EUDAMED	Class I	Active
NeilMed NasaMist Saline Spray (Extra Strength)	6008ST-FRN-INT	EUDAMED	Class I	Active
NeilMed Sinus Rinse	5003IFU-ADU-FRN	EUDAMED	Class I	Active
NeilMed NasaMist Isotonic Saline Spray	6014ST-FRN-INT	EUDAMED	Class I	Active
NeilMed Sinus Rinse 60 Premixed Sachets	5003IFU-ADU-FRN	EUDAMED	Class I	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 28, 2024	Z-1105-2025	—	open, classified	Due to nasal spray stability failure for bioburden.