Dornier Medtech America, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 46
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1381-2019 | Class II | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K100 | April 1, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1 | January 31, 2025 |
| K233380 | TRIDENT Mobile Fluoroscopy System | June 26, 2024 |
| K221903 | Delta III Pro | February 22, 2023 |
| K213252 | Dornier Thulio | July 27, 2022 |
| K220871 | Nautilus | April 18, 2022 |
| K210394 | Electrosurgical accessory | May 19, 2021 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | November 20, 2020 |
| K201074 | Delta III Lithotripter | September 3, 2020 |
| K190612 | EQUINOX Balloon Dilatation Catheter | December 6, 2019 |
| K190312 | Dornier Ureteral Stent | November 15, 2019 |
| K191187 | Dornier MINNOW Ureteral Catheter | September 18, 2019 |
| K180350 | Dornier Medilas H Solvo 35 Laser | March 7, 2018 |
| K172084 | Delta III Lithotripter | August 8, 2017 |
| K170122 | Delta III Lithotripter | June 28, 2017 |
| K161771 | Medilas H Laser Fibers | July 28, 2016 |
| K152591 | Medilas H RFID Laser Fibers | October 8, 2015 |
| K151298 | Gemini XXP-HP | July 30, 2015 |
| K151485 | GENESIS | June 30, 2015 |
| K133434 | GENESIS II | November 26, 2014 |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | September 23, 2013 |