Ultrasonic Medical Devices (Miscellaneous)
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
| Radiation Type | Acoustic |
| Radition Safety | None |
| Annual Reports | No |
| 2209 | Device, Ultrasonic, Thermal Ablation |
| 2209 | Device, Ultrasonic, Thermal Ablation |
| Device, Ultrasonic, Thermal Ablation [32395] | 21 CFR Unclassified 🔎 |
| INSIGHTEC EXABLATE 2000 | INSIGHTEC | 2010-01-28 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2007-08-27 |
| RF CARDIAC ABLATION CONTROLLER SYSTEM | BOSTON SCIENTIFIC CORP., EP TECHNOLOGIES | 2007-04-09 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2007-02-26 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2007-01-04 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2007-01-04 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2006-11-01 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2006-11-01 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2006-04-06 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2006-04-06 |
| EXABLATE 2000 | INSIGHTEC, LTD. | 2006-02-21 |
| CARDIAC ABLATION CONTROLLER | BOSTON SCIENTIFIC | 2005-07-14 |
| MEDTRONIC | MEDTRONIC, INC. | 2005-04-13 |
| CARDIAC ABLATION SYSTEM | BOSTON SCIENTIFIC | 2005-04-11 |
| *CARDIAC ABLATION CATHETER | BOSTON SCIENTIFIC CORP. | 2005-04-11 |
| SONOBLATE-500 | FOCUS SURGERY, INC. | 2004-09-22 |
| INSIGHT-TXSONICS, INC. | WESTERN INSTITUTIONAL REVIEW BOARD | 2003-02-13 |
| MK2 - EXABLATE | INSIGHTEC-TXSONICS | 2001-05-19 |
| UNKTRANS URETHRAL NEEDLE ABLATION DEVICE | UNK | 1998-09-02 |
| VIDAMED TUNA SYSTEM | VIDAMED, INC. | 1998-07-01 |