Dyna-Med
Country not established
- Devices
- 4
What Dyna-Med makes
Dyna-Med manufactures obstetrical kits for clinical use, as well as bite sticks designed to manage patient agitation or restraint. Their portfolio includes ultrasound imaging systems like the Polarix 2 and Polarix 2E, which are used for diagnostic imaging, and a series of ambu bags (AMX-110, AMX-II, AMX-III) for manual ventilation in emergency or surgical settings.
The company’s devices are classified under FDA regulations as Class I and Class II, with relevant products listed under the 510(k) pathway. These products are intended for use in the United States, where Dyna-Med is based.
Catalogue
Obstetrical Kit Ref K863504
510(k) 510(k)Polarix 2 And Polarix 2E Ref K884578
510(k) 510(k)Amx-110, Amx-Ii And Amx-Iii Ref K884340
510(k) 510(k)Bite Stick, Dyna Ref K760258
510(k) 510(k)
Frequently asked questions
How many devices does Dyna-Med have in the registry?
The registry currently lists 4 devices for Dyna-Med. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dyna-Med's devices?
Among its 4 most recently registered devices, Dyna-Med has devices listed in FDA 510(k) (4 devices).
What risk classes do Dyna-Med's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Dyna-Med's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dyna-Med in the registry?
The most recently registered devices listed for Dyna-Med include OBSTETRICAL KIT, POLARIX 2 AND POLARIX 2E, AMX-110, AMX-II AND AMX-III and BITE STICK, DYNA.