Madison Polymeric Engineering
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 2
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1925-2019 | Class II | First Step Draco Pad, Product Number EP-4D | May 8, 2019 |
| Z-1924-2019 | Class II | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z | May 8, 2019 |
| Z-0969-2019 | Class II | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic | December 14, 2018 |
| Z-1897-2018 | Class II | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean | March 21, 2018 |
| Z-1899-2018 | Class II | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside | March 21, 2018 |
| Z-1896-2018 | Class II | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Numbe | March 21, 2018 |
| Z-1895-2018 | Class II | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Numbe | March 21, 2018 |
| Z-1900-2018 | Class II | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Num | March 21, 2018 |
| Z-1898-2018 | Class II | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Numbe | March 21, 2018 |
| Z-1182-2018 | Class II | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface o | November 3, 2017 |
| Z-2211-2017 | Class II | Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z | April 17, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K964256 | CYGNUS INSTRUMENT PROTECTORS | May 6, 1997 |
| K965086 | CYGNUS ELECTROSURGICAL TIP CLEANER | February 14, 1997 |