Home › Device types › KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
FDA product code KHJ · Class 2 · Ear, Nose, Throat
91
Registered devices
24
Adverse events
2
Recalls
34
510(k) clearances
Devices with this code
GYRUS ACMI, INC — Gyrus ACMI, LLCORCA Foam — Orca Products, LLCBiodesign — COOK BIOTECH INCORPORATEDORCA Foam — Orca Products, LLCORCA Foam Powder — Orca Products, LLCEXMOOR — EXMOOR PLASTICS LIMITEDEXMOOR — EXMOOR PLASTICS LIMITEDProlaryn Plus — MERZ NORTH AMERICA, INC.EpiDisc TM Perf Patch Kit — Anika Therapeutics, Inc.GELITA-SPON® STANDARD — GELITA MEDICAL GmbHNA — MEDTRONIC XOMED, INC.ORCA Foam Powder — Orca Products, LLCEXMOOR — EXMOOR PLASTICS LIMITEDORCA Foam — Orca Products, LLCGELITA-SPON® STANDARD — GELITA MEDICAL GmbHBiodesign — COOK BIOTECH INCORPORATEDNA — MEDTRONIC XOMED, INC.N/A — MEDTRONIC XOMED, INC.GYRUS ACMI, INC — Gyrus ACMI, LLCGYRUS ACMI, INC — Gyrus ACMI, LLCORCA Foam — Orca Products, LLCORCA Foam — Orca Products, LLCTitanium-Vocal-Fold-Medial-Implant — Heinz Kurz GmbHEXMOOR — EXMOOR PLASTICS LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
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