Panels › Physical Medicine › Product code KFX · Class 2
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Regulation 890.3500
0510(k)s in 12 months (4 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in KFX
| Company | 510(k)s | Recalls |
|---|---|---|
| LeMaitre Vascular, Inc. | 0 | 2 |
| American Mcgaw | 1 | 0 |
| Besco Financial Service | 1 | 0 |
| Bock,Otto,Orthopedic Ind,Inc | 0 | 1 |
| Ipos Luneburg | 1 | 0 |
| Vascutech, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2013 | LeMaitre Vascular, Inc. Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).
Intended to be placed on the skin to assist during imaging procedures. Terminated |
KFX | K932184 |
| Apr 4, 2013 | LeMaitre Vascular, Inc. LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).
Intended to be placed on the skin to assist during imaging procedures. Terminated |
KFX | K932184 |
| Jan 25, 2007 | Bock,Otto,Orthopedic Ind,Inc Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint u Terminated |
KFX | K991590 |
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