Unimed Surgical Products, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 13
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1347-2013 | Class II | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of | February 15, 2013 |
| Z-2288-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" | June 16, 2010 |
| Z-2287-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reord | June 16, 2010 |
| Z-2293-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 | June 16, 2010 |
| Z-2292-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reord | June 16, 2010 |
| Z-2289-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reord | June 16, 2010 |
| Z-2295-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 | June 16, 2010 |
| Z-2290-2012 | Class II | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81 ) Length***Reorde | June 16, 2010 |
| Z-2291-2012 | Class II | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 | June 16, 2010 |
| Z-2296-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 ( | June 16, 2010 |
| Z-2286-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES | June 16, 2010 |
| Z-2294-2012 | Class II | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reor | June 16, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | October 8, 2013 |
| K993647 | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DI | November 16, 1999 |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE | February 18, 1997 |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | October 21, 1996 |
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | September 3, 1996 |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | July 25, 1995 |
| K944265 | NEEDLE ELCTRODE | May 5, 1995 |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | March 7, 1995 |
| K945030 | SURGI-LINK LAPAROSCOPIC ELECTRODES | November 3, 1994 |
| K944898 | SURGI-LINK BIPOLAR ELECTRODES | November 1, 1994 |
| K944617 | SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL | September 29, 1994 |
| K944433 | SURGI-LINK ELECTROSURGICAL ELECTRODE | September 26, 1994 |
| K944045 | SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS | September 8, 1994 |