Infinitech, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Infinitech, Inc. makes
Infinitech, Inc. manufactures endoscopic and ophthalmic tools, including illuminated pick manipulators for minimally invasive procedures, endo-illuminators with integrated irrigation, and slit lamp laser adapters for precise retinal surgery. Their portfolio also covers otolaryngology tools like the Otoprobe and respiratory aids such as the Breath EZ, alongside high-intensity xenon light sources for surgical illumination.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the 510(k) clearance database. These products are listed under U.S. jurisdiction, reflecting compliance with U.S. medical device regulations.
Catalogue
- Regimes: 510(k) Registry: 510(k)
End-Irrigating Endoilluminator Ref K931546
Regimes: 510(k) Registry: 510(k)Infinitech Multi-Spot Slit Lamp Laser Adapter Ref K971950
Regimes: 510(k) Registry: 510(k)Infinitech Breath Ez Ref K935441
Regimes: 510(k) Registry: 510(k)Infinitech Otoprobe Ref K931264
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Infinitech, Inc. have in the registry?
The registry currently lists 6 devices for Infinitech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Infinitech, Inc.'s devices?
Among its 6 most recently registered devices, Infinitech, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Infinitech, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Infinitech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Infinitech, Inc. in the registry?
The most recently registered devices listed for Infinitech, Inc. include INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR, END-IRRIGATING ENDOILLUMINATOR, INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER and INFINITECH BREATH EZ.