Angiodynamics, Div. E-Z-Em, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Angiodynamics, Div. E-Z-Em, Inc. makes
Angiodynamics, a division of E-Z-Em, Inc., manufactures medical devices for vascular and interventional procedures, including the MicroGuide Lesion Marking System for catheter navigation and marking, as well as Angiography Syringe Kits for contrast media delivery. The company also produces the Pulse*Spray Infusion System, designed for controlled drug or contrast agent infusion during procedures.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with several products authorised via the 510(k) pathway. These devices are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Microguide Lesion Marking System Ref K923120
510(k) 510(k)Pulse*spray Infusion System Ref K951509
510(k) 510(k)Pulse*spray Infusion System Ref K961763
510(k) 510(k)Angiography Syringe Kits Ref K933846
510(k) 510(k)Pulse*spray Infusion System Ref K950907
510(k) 510(k)Pulse*spray Infusion System Ref K951602
510(k) 510(k)
Frequently asked questions
How many devices does Angiodynamics, Div. E-Z-Em, Inc. have in the registry?
The registry currently lists 6 devices for Angiodynamics, Div. E-Z-Em, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Angiodynamics, Div. E-Z-Em, Inc.'s devices?
Among its 6 most recently registered devices, Angiodynamics, Div. E-Z-Em, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Angiodynamics, Div. E-Z-Em, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Angiodynamics, Div. E-Z-Em, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Angiodynamics, Div. E-Z-Em, Inc. in the registry?
The most recently registered devices listed for Angiodynamics, Div. E-Z-Em, Inc. include MICROGUIDE LESION MARKING SYSTEM, PULSE*SPRAY INFUSION SYSTEM and ANGIOGRAPHY SYRINGE KITS.