| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018250 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018267 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018274 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018281 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018298 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018304 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018311 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018328 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018335 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018342 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| MENTOR Round Ultra High Profile Sterile Resterilizable Gel Breast Implant Sizer | 08717694018359 | MENTOR MEDICAL SYSTEMS B.V. | Class IIa | |
| Motiva Flora | 07445161009487 | Establishment Labs | Class I | |
| Motiva Inflatable Balloon | 07445161006400 | Establishment Labs | Class IIa | |
| Motiva Inflatable Balloon | 07445161006417 | Establishment Labs | Class IIa | |
| Motiva Inflatable Balloon | 07445161009494 | Establishment Labs | Class IIa | |
| Motiva Inflatable Balloon | 07445161009579 | Establishment Labs | Class IIa | |
| Motiva Inflatable Balloon | 07445161009586 | Establishment Labs | Class IIa | |
| Motiva Injector | 07445161006424 | Establishment Labs | Class IIa | |
| Motiva Injector | 07445161006431 | Establishment Labs | Class IIa | |
| Motiva Injector | 07445161009548 | Establishment Labs | Class IIa | |
| Motiva Injector | 07445161009555 | Establishment Labs | Class IIa | |
| Motiva Insertion Sleeve | 08800071700098 | Kims Med Co., Ltd. | Class IIa | |
| VCONE | 08800071700074 | Kims Med Co., Ltd. | Class IIa | |