Radionics, Inc.
United StatesFDA applicant, unverified
- Devices
- 56
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Radionics, Inc. makes
Radionics, Inc. manufactures disposable radiofrequency (RF) cannulae for surgical procedures, including variants for specific applications like the SC-C and RFK-DB models. Their portfolio includes medical imaging tools such as the Ocular-Biometer 4000 for eye measurements and the Slice Editor imaging software utility for medical imaging refinement. Additionally, they produce cardiac devices like the PACE-1A cardiac stimulator and the Ojemann Cortical Stimulator for neurosurgical applications, as well as specialized surgical instruments such as the Burr Hole Valve and Linac couch-mount systems for radiation therapy. The company also supplies catheter passers for vascular procedures and depth electrode kits for neurological assessments.
The company’s devices are classified under FDA categories Class I and Class II, with several products listed via the 510(k) pathway. These regulatory designations apply to medical instruments, imaging tools, and surgical implants used in ophthalmology, cardiology, neurosurgery, and radiation therapy. Radionics, Inc. is headquartered in the United States.
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
FDA recalls
FDA recall records list 1 recall initiated by Radionics, Inc., initiated on 2004-05-25. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 25 May 2004 Z-1020-04 Unclassified (pre-2012) Terminated Software may provide inaccurate coordinates and cause mistreatment
Frequently asked questions
How many devices does Radionics, Inc. have in the registry?
The registry currently lists 56 devices for Radionics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radionics, Inc.'s devices?
Among its 50 most recently registered devices, Radionics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Radionics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Radionics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Radionics, Inc.?
FDA recall records list 1 recall initiated by Radionics, Inc., the most recent initiated on 25 May 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Radionics, Inc. in the registry?
The most recently registered devices listed for Radionics, Inc. include RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS), RFG-3CF, RADIONICS MICROELECTRODE KIT and RADIONICS XDC EXTERNAL VENTRICULAR CATHETER.