Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Blazer-C Curved Injection System | BZK3140 | Izi Medical Products, LLC | OCJ | 00815212023583 |
| Kiva | PLT1900 | BENVENUE MEDICAL, INC. | OCJ | 00813478020063 |
| Blazer | BCN3120 | BENVENUE MEDICAL, INC. | OCJ | 00813478020186 |
| Kiva | PLT1910 | BENVENUE MEDICAL, INC. | OCJ | 00813478020070 |
| BLAZER INTRODUCER,BEVEL TIP | ACC3140 | Izi Medical Products, LLC | OCJ | 00815212023637 |
| Blazer | BZK3130 | BENVENUE MEDICAL, INC. | OCJ | 00813478020193 |
| BLAZER:C VAS | BCN3120 | Izi Medical Products, LLC | OCJ | 00815212023477 |
| BLAZER-C CURVED INJECTION SYSTEM-MV | BZK3160 | Izi Medical Products, LLC | OCJ | 00815212026973 |
| KIVA Gen 2 Bone Drill | ACC5225 | Izi Medical Products, LLC | OCJ | 00815212023644 |
| Blazer Introducer - diamond tip | ACC3130 | Izi Medical Products, LLC | OCJ | 00815212023620 |
| Blazer Bone Drill | ACC3120 | Izi Medical Products, LLC | OCJ | 00815212023613 |