Panels › General, Plastic Surgery › Product code NEY · Class 2
System, Ablation, Microwave And Accessories
Regulation 878.4400
2510(k)s in 12 months (68 all time)
0recalls in 12 months (27 all time)
25recalls that name a 510(k)
Top companies in NEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien, LLC | 5 | 11 |
| AngioDynamics, Inc. | 5 | 10 |
| Neuwave Medical, Inc. | 10 | 0 |
| Angiodynamics Inc. (Navilyst Medical Inc.) | 0 | 5 |
| Creo Medical, Ltd. | 4 | 0 |
| Emblation , Ltd. | 4 | 0 |
| Medwaves Incorporated | 4 | 0 |
| Miramar Labs, Inc. | 3 | 0 |
| Afx, Inc. | 2 | 0 |
| Betters(Suzhou) Medical Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2010 | K100786 | MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX Bsd Medical Corp. | NEY |
| Aug 6, 2010 | K094021 | ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I Microsulis Medical Limited, GB | NEY |
| Sep 29, 2009 | K083157 | HS AMICA H.S Hospital Service S.P.A | NEY |
| Mar 20, 2009 | K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 Miramar Labs, Inc. | NEY |
| Feb 12, 2009 | K082565 | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 Microsurgeon, Inc. | NEY |
| Jan 15, 2009 | K083537 | MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM Medwaves Incorporated | NEY |
| Nov 25, 2008 | K072687 | VALLEYLAB MICROWAVE ABLATION GENERATOR Covidien Lp, Formerly Know AS Valleylab, A Divison | NEY |
| Sep 3, 2008 | K081042 | MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES Bsd Medical Systems Corp. | NEY |
| Jan 14, 2008 | K072870 | MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) Foundry Newco X, Inc. | NEY |
| Dec 18, 2007 | K070356 | MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM Medwaves Incorporated | NEY |
| Aug 15, 2007 | K070023 | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 Microsurgeon, Inc. | NEY |
| Jul 27, 2006 | K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 Guidant Corp. | NEY |
| Apr 27, 2006 | K053535 | VIVAWAVE MICROWAVE ABLATION SYSTEM Valleylab | NEY |
| Jan 13, 2006 | K052919 | MICROSULIS TISSUE ABLATION SYSTEM Microsulis Americas, Inc. | NEY |
| Jul 28, 2004 | K041340 | GUIDANT MICROWAVE ABLATION SYSTEM Guidant Corporation, Cardiac Surgery | NEY |
| Jun 18, 2002 | K011676 | VIVAWAVE MICROWAVE SYSTEM Vivant Medical, Inc. | NEY |
| Feb 27, 2002 | K013946 | FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM Afx, Inc. | NEY |
| May 22, 2001 | K003978 | AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 Afx, Inc. | NEY |
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