Home › Device types › NEY
System, Ablation, Microwave And Accessories
FDA product code NEY · Class 2 · General, Plastic Surgery
337
Registered devices
1,807
Adverse events
27
Recalls
68
510(k) clearances
Devices with this code
Betters (Suzhou)Medical Co., Ltd. — Betters (Suzhou)Medical Co., Ltd.NEUWAVE — NEUWAVE MEDICAL, INC.SynchroWave Antenna Kit — Varian Medical Systems, Inc.HEATfx Microwave Ablation System — GALIL MEDICAL INC.Microwave Ablation Antennas — Canyon Medical Inc.Betters (Suzhou)Medical Co., Ltd. — Betters (Suzhou)Medical Co., Ltd.SynchroWave Antenna Kit — PERSEON CORPORATIONDophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.Emprint — Covidien LPHYGEA — Hygea Medical Technology Co., Ltd.SynchroWave Antenna Kit — PERSEON CORPORATIONEvident — Covidien LPEvident — Covidien LPSolero — ANGIODYNAMICS, INC.SynchroWave Antenna Kit — PERSEON CORPORATIONNEUWAVE — NEUWAVE MEDICAL, INC.ECO Disposable microwave therapeutic antenna — ECO Medical Technology (Nanjing) Co., Ltd.MicroThermX Microwave Ablation System — Varian Medical Systems, Inc.SynchroWave LT Antenna — Varian Medical Systems, Inc.swiftPro Cradle — EMBLATION LIMITEDHYGEA — Hygea Medical Technology Co., Ltd.Microwave Ablation Antennas — Canyon Medical Inc.NEUWAVE — NEUWAVE MEDICAL, INC.ECO Disposable microwave therapeutic antenna — ECO Medical Technology (Nanjing) Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-23 | Covidien, LLC | The product is labeled with the incorrect expiration date. |
| 2021-09-29 | Covidien Llc | The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling sys |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during |
| 2021-07-20 | Angiodynamics, Inc. | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in perfo |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in perfo |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in perfo |
| 2019-04-17 | Angiodynamics Inc. (Navilyst Medical Inc.) | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in perfo |
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