Home › Device types › KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
FDA product code KHJ · Class 2 · Ear, Nose, Throat
90
Registered devices
23
Adverse events
2
Recalls
33
510(k) clearances
Devices with this code
EpiDisc TM Perf Patch Kit — Anika Therapeutics, Inc.ORCA Foam — Orca Products, LLCORCA Foam — Orca Products, LLCGYRUS ACMI, INC — Gyrus ACMI, LLCEXMOOR — EXMOOR PLASTICS LIMITEDGYRUS ACMI, INC — Gyrus ACMI, LLCEpifilm Otologic — Anika Therapeutics, Inc.GYRUS ACMI, INC — Gyrus ACMI, LLCTitanium-Vocal-Fold-Medial-Implant — Heinz Kurz GmbHMeroGel Otologic Packing 1x5cm — Anika Therapeutics, Inc.EpiDisc TM Perf Patch Kit — Anika Therapeutics, Inc.EXMOOR — EXMOOR PLASTICS LIMITEDBiodesign — COOK BIOTECH INCORPORATEDEpidisc 2pk Otologic 8mm — Anika Therapeutics, Inc.Biodesign — COOK BIOTECH INCORPORATEDORCA Foam Powder — Orca Products, LLCN/A — MEDTRONIC XOMED, INC.NA — MEDTRONIC XOMED, INC.GELITA-SPON® STANDARD — GELITA MEDICAL GmbHBiodesign — COOK BIOTECH INCORPORATEDN/A — MEDTRONIC XOMED, INC.GYRUS ACMI, INC — Gyrus ACMI, LLCBIODESIGN — COOK BIOTECH INCORPORATEDNA — MEDTRONIC XOMED, INC.
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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