Repro-Med Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 6
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0051-2020 | Class II | 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product U | August 20, 2019 |
| Z-0318-2018 | Class II | HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS2 | March 10, 2016 |
| Z-0317-2018 | Class II | Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, | March 10, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102512 | RMS SUBCUTANEOUS NEEDLE SET | May 20, 2011 |
| K981506 | RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY | June 25, 1998 |
| K933652 | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING | May 18, 1994 |
| K894299 | REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM | September 22, 1989 |
| K892529 | REPRO-MED NEONATE ASPIRATION SYSTEM | June 12, 1989 |
| K844401 | REPRO-MED SYSTEMS INFUSION DEVICE | March 12, 1985 |