Panels › General, Plastic Surgery › Product code NTB · Class 2
System, Ablation, Ultrasound And Accessories
Regulation 878.4400
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NTB
| Company | 510(k)s | Recalls |
|---|---|---|
| Epicor Medical, Inc. | 2 | 0 |
| Misonix, Inc. | 2 | 0 |
| Acoustic Medsystems, Inc. | 1 | 0 |
| Ultrazonix Dnt AB | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2016 | K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators Acoustic Medsystems, Inc. | NTB |
| Jul 9, 2008 | K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM Misonix, Inc. | NTB |
| Dec 22, 2006 | K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM Ultrazonix Dnt AB | NTB |
| Jan 26, 2006 | K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM Misonix, Inc. | NTB |
| May 5, 2004 | K040641 | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 Epicor Medical, Inc. | NTB |
| Feb 26, 2004 | K022894 | EPICOR MEDICAL ABLATION SYSTEM Epicor Medical, Inc. | NTB |
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