Is this your brand? Sign in to claim ownership.

Osprey Medical, Inc.

Last updated May 30, 2026

What Osprey Medical, Inc. makes

Osprey Medical, Inc. manufactures devices designed to manage and monitor contrast media in medical imaging procedures, including automated contrast medium conservation systems and disposable monitoring kits. Their portfolio includes smart syringe systems for precise fluid delivery and contrast monitoring solutions to track usage in real time, as well as contrast diversion systems for reducing waste during imaging studies.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Osprey Medical, Inc. manufacture?

Osprey Medical, Inc. specializes in devices that help manage and monitor contrast media during medical imaging procedures. Their primary focus is on contrast medium conservation systems, such as automated diversion systems (e.g., DYEVERT™ PLUS) and smart syringe solutions (e.g., SMART SYRINGE) for precise fluid delivery. They also produce disposable monitoring kits (e.g., DYETECT™) to track contrast media usage in real time, helping reduce waste and improve efficiency in imaging workflows.

Where is Osprey Medical, Inc. based, and where are their devices intended for use?

Osprey Medical, Inc. is headquartered in the United States. Their devices are designed and marketed for use within the U.S. regulatory environment, where they are subject to FDA oversight.

Which regulatory databases list Osprey Medical’s devices?

Osprey Medical’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways for market authorization in the U.S.

How are Osprey Medical’s devices classified under FDA regulations?

All of Osprey Medical’s listed devices fall under Class II classification by the FDA. This classification indicates moderate regulatory controls are applied, as these devices pose a lower risk compared to Class III but still require validation of safety and performance through processes like the 510(k) pathway.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: ospreymed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 9529558247
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 938215568

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
Smart Monitor	SMART	FDA UDI	Class II	Active
Dyevert™ Plus Ez	LV-EZ-RRL	FDA UDI	Class II	Active
Dyevert™ Plus Ez	LV-EZ-PRS	FDA UDI	Class II	Active
DYETECT™ Contrast Monitoring Disposable Kit	RRL	FDA UDI	Class II	Active
Smart Syringe	R-RRS	FDA UDI	Class II	Active
Dyevert™ Plus Ez	HV-EZ-PRS	FDA UDI	Class II	Active
Dyevert™ Plus	LVOFF-RRS	FDA UDI	Class II	Active
Dyevert™ Plus	HVOFF-RRS	FDA UDI	Class II	Active
Dyevert™ Plus Ez	HV-EZ-PRL	FDA UDI	Class II	Active
Dyevert™ Plus Ez	LV-EZ-RRS	FDA UDI	Class II	Active
DYETECT™ Contrast Monitoring Disposable Kit	PWL	FDA UDI	Class II	Active
DyeVert	AA-HV	FDA UDI	Class II	Unknown
Dyevert™ Plus	HVOFF-PWL	FDA UDI	Class II	Active
Smart Syringe	R-PRS	FDA UDI	Class II	Active
Dyevert™ Plus Ez	HV-EZ-RRL	FDA UDI	Class II	Active
Smart Syringe	R-RRL	FDA UDI	Class II	Active
Dyevert™ Plus	LVOFF-PWL	FDA UDI	Class II	Active
Dyevert™ Plus Ez	HV-EZ-PWL	FDA UDI	Class II	Active
Dyevert™ Plus	LVOFF-PRS	FDA UDI	Class II	Active
Dyevert™ Plus Ez	LV-EZ-PRL	FDA UDI	Class II	Active
Dyevert™ Plus Ez	HV-EZ-RRS	FDA UDI	Class II	Active
DYETECT™ Contrast Monitoring Disposable Kit	PRS	FDA UDI	Class II	Active
Smart Syringe	R-PRL	FDA UDI	Class II	Active
DyeVert	AA-LV	FDA UDI	Class II	Unknown
Smart Syringe	R-PWL	FDA UDI	Class II	Active
Dyevert™ Plus	HVOFF-PRS	FDA UDI	Class II	Active
Dyevert™ Plus	CMW	FDA UDI	Class II	Active
DYETECT™ Contrast Monitoring Disposable Kit	PRL	FDA UDI	Class II	Active
Dyevert™ Plus Ez	LV-EZ-PWL	FDA UDI	Class II	Active
DYETECT™ Contrast Monitoring Disposable Kit	RRS	FDA UDI	Class II	Active
Dyevert™ Ng	HVOFF	FDA UDI	Class II	Active
Dyevert™ Ng	LVOFF	FDA UDI	Class II	Active
Smart Syringe	K171698	FDA 510(k)	Class II	Active
DyeVert PLUS EZ Contrast Reduction System	K181936	FDA 510(k)	Class II	Active
DyeVert NG Contrast Modulation System	K161505	FDA 510(k)	Class II	Active
Contrast Modulation System	K140425	FDA 510(k)	Class II	Active
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System	K183267	FDA 510(k)	Class II	Active
AVERT Contrast Modulation System	K151300	FDA 510(k)	Class II	Active
DyeVert Contrast Modulation System	K153141	FDA 510(k)	Class II	Active
AVERT Contrast Modulation System	K150485	FDA 510(k)	Class II	Active
AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System	K152218	FDA 510(k)	Class II	Active
Dyevert Contrast Modulation System	K151746	FDA 510(k)	Class II	Active
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System	K163054	FDA 510(k)	Class II	Active
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System	K171217	FDA 510(k)	Class II	Active
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System	K190102	FDA 510(k)	Class II	Active
Contrast Monitoring System Display, Contrast Monitoring System Syringes	K142081	FDA 510(k)	Class II	Active
Contrast Conservation System	K131478	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.