Panels › Ear, Nose, Throat › Product code KHJ · Class 2
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation 874.3620
1510(k)s in 12 months (34 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ceremed , Inc. | 8 | 0 |
| Xomed, Inc. | 5 | 0 |
| Cook Biotech Incorporated | 2 | 1 |
| Cook Biotech Incorprated | 2 | 0 |
| Curamedical, BV | 2 | 0 |
| Exmoor Plastics , Ltd. | 2 | 0 |
| Bioform, Inc. | 1 | 0 |
| Bioplexus Corp. | 1 | 0 |
| Cambridgemed | 1 | 0 |
| Doctor'S Research Group, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. Open, Classified |
KHJ | K232646 |
| Dec 3, 2015 | Merz North America, Inc. PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency. Terminated |
KHJ | K013243 |
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