Phoenix Biomedical Corp.
United StatesFDA applicant, unverified
- Devices
- 13
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Phoenix Biomedical Corp. makes
Phoenix Biomedical Corp. manufactures ventricular shunt systems, including gravity-compensating reservoirs and valves like the Diamond II, CRX Diamond, and Phoenix CRX, designed for cerebrospinal fluid (CSF) management. Their portfolio also includes drainage systems such as the Rumbar Drainage System, suture cords, and tissue extension systems like the Phoenix ETE. Lumbar-peritoneal shunt systems and universal shunt systems are also part of their product line.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory authorisation via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 1 recall initiated by Phoenix Biomedical Corp., initiated on 2004-01-06. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 6 Jan 2004 Z-0585-04 Unclassified (pre-2012) Terminated mislabeled - product actually Single Valve
Frequently asked questions
How many devices does Phoenix Biomedical Corp. have in the registry?
The registry currently lists 13 devices for Phoenix Biomedical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phoenix Biomedical Corp.'s devices?
Among its 13 most recently registered devices, Phoenix Biomedical Corp. has devices listed in FDA 510(k) (13 devices).
What risk classes do Phoenix Biomedical Corp.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Phoenix Biomedical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Phoenix Biomedical Corp.?
FDA recall records list 1 recall initiated by Phoenix Biomedical Corp., the most recent initiated on 6 Jan 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 Phoenix Biomedical Corp. in the registry?
The most recently registered devices listed for Phoenix Biomedical Corp. include PERF (OMMAYA STYLE) RESERVOIRS, RUMBAR DRAINAGE SYSTEM, SUTURE CORD and DIAMOND II VALVE.