This company has registrations in United States, Canada, Taiwan, South Korea, Israel — 5 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle | 2020-11-02 |
| US | K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | 2020-07-09 |
| US | K181741 | IceSphere 1.5 CX Cryoablation Needle | 2018-07-30 |
| CA | 105027 | HEATFX MICROWAVE ABLATION SYSTEM | Class III |
| CA | 64119 | SEEDNET CRYOABLATION SYSTEM | Class III |
| CA | 74706 | PRESICE CRYOSURGICAL SYSTEM | Class III |