510(k) K954465 ยท HRX Arthroscope
FMS DUO
| Applicant | Future Medical Systems, Inc., New York City NY, US |
| Decision | Substantially Equivalent, Nov 9, 1995 |
| Received | Sep 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2016 | DePuy Mitek, Inc., a Johnson & Johnson Co. FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325
Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. Terminated |
HRX | None listed |
| Nov 8, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Outflow Tubing with One-Way valve
Product Code:284649
Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath du Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.