Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 70AND2 | Edwards Lifesciences LLC | DXG | 00690103181548 |
| (unnamed) | 64EKH | Edwards Lifesciences LLC | DXG | 00690103002461 |
| (unnamed) | 64EKMM | Edwards Lifesciences LLC | DXG | 00690103002508 |
| (unnamed) | 64EKD2 | Edwards Lifesciences LLC | DXG | 00690103181470 |
| (unnamed) | 70ANHS | Edwards Lifesciences LLC | DXG | 00690103002676 |
| (unnamed) | 70ANSS | Edwards Lifesciences LLC | DXG | 00690103002782 |
| (unnamed) | OM2 | Edwards Lifesciences LLC | DXG | 00690103008463 |
| (unnamed) | COM2CC | Edwards Lifesciences LLC | DXG | 00690103005271 |
| (unnamed) | 70ANNK | Edwards Lifesciences LLC | DXG | 00690103002768 |
| (unnamed) | 64EKSM | Edwards Lifesciences LLC | DXG | 00690103191165 |
| (unnamed) | 64EKD | Edwards Lifesciences LLC | DXG | 00690103181463 |
| (unnamed) | 70ANS | Edwards Lifesciences LLC | DXG | 00690103002775 |
| (unnamed) | 64EKNK1 | Edwards Lifesciences LLC | DXG | 00690103181500 |
| (unnamed) | 64EKGE1 | Edwards Lifesciences LLC | DXG | 00690103181494 |
| SWAN-GANZ | 70CC2 | Edwards Lifesciences LLC | DXG | 00690103002799 |
| (unnamed) | 64EKGE2 | Edwards Lifesciences LLC | DXG | 00690103186086 |
| (unnamed) | 64EKBB | Edwards Lifesciences LLC | DXG | 00690103002454 |
| (unnamed) | 70AND3 | Edwards Lifesciences LLC | DXG | 00690103181555 |
| (unnamed) | 70ANH | Edwards Lifesciences LLC | DXG | 00690103002614 |
| (unnamed) | 70ANM7 | Edwards Lifesciences LLC | DXG | 00690103181579 |
| CO-SET+ | 9850A | Edwards Lifesciences LLC | DXG | 00690103004250 |
| (unnamed) | 64EKLL | Edwards Lifesciences LLC | DXG | 00690103002485 |
| (unnamed) | 70ANM6 | Edwards Lifesciences LLC | DXG | 00690103181562 |
| (unnamed) | 64EKHH | Edwards Lifesciences LLC | DXG | 00690103002478 |
| (unnamed) | 70ANM5 | Edwards Lifesciences LLC | DXG | 00690103002737 |