Medtronic Advanced Energy, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1128-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usag | December 28, 2016 |
| Z-1132-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Us | December 28, 2016 |
| Z-1130-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usag | December 28, 2016 |
| Z-1133-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usag | December 28, 2016 |
| Z-1126-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usag | December 28, 2016 |
| Z-1136-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usag | December 28, 2016 |
| Z-1134-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usag | December 28, 2016 |
| Z-1131-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usag | December 28, 2016 |
| Z-1129-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Us | December 28, 2016 |
| Z-1127-2017 | Class II | Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usag | December 28, 2016 |
| Z-1135-2017 | Class II | Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Us | December 28, 2016 |
| Z-0905-2014 | Class II | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator as | November 12, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183129 | Medtronic Total Hip Arthroplasty System | July 26, 2019 |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | August 2, 2018 |
| K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | September 7, 2017 |
| K170610 | PlasmaBlade T | April 13, 2017 |
| K170296 | CoreCath 2.7S | March 20, 2017 |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | July 8, 2016 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | May 21, 2015 |
| K143175 | AEx Generator; PlasmaBlade T | December 31, 2014 |
| K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS | December 3, 2013 |
| K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | January 10, 2013 |
| K120909 | EC 2.7 ENDOSCOPIC CUTTER | November 2, 2012 |