Procedure Products, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 16
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0355-2016 | Class II | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-ste | October 27, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161812 | Freedom Syringe | March 27, 2017 |
| K923194 | INSUFFLATOR CONNECTING FILTER | October 8, 1993 |
| K922536 | TORQUE DEVICE | December 10, 1992 |
| K914128 | CONNECTING SET | November 27, 1991 |
| K910673 | BAG SPIGOT | April 24, 1991 |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | December 20, 1988 |
| K874747 | 10CC SYRINGE CONTROL RING SET | February 4, 1988 |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | January 29, 1988 |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | January 13, 1986 |
| K842173 | DISPOSABLE STOPCOCKS | September 5, 1984 |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | March 12, 1984 |
| K820384 | GLASS SYRINGES, DRUG, LUER LOCK | April 15, 1982 |
| K812657 | INJECTION CAP, LUER LOCK | October 23, 1981 |
| K811548 | CERVICAL SPATULA | June 23, 1981 |
| K810921 | MALE LUER LOCK PLUGS | May 21, 1981 |
| K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL | April 11, 1981 |