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FDA product code KAI · Class 1 · Ear, Nose, Throat
506
Registered devices
4
Adverse events
1
Recalls
9
510(k) clearances
Devices with this code
Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftBausch + Lomb — Bausch & Lomb IncorporatedHahnenkratt — E. Hahnenkratt GmbHMillennium — Avalign Technologies, Inc.MIRROR — KLS-Martin L.P.Ambler Surgical — AMBLER SURGICAL CORP.Avalign — Avalign Technologies, Inc.Ambler Surgical — AMBLER SURGICAL CORP.mytaMed — Mytamed, Inc.Symmetry Hardy™ — ASPEN SURGICAL PRODUCTS, INC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHAESCULAP — Aesculap AGMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.MILLENNIUM — Avalign Technologies, Inc.PILLING — TELEFLEX INCORPORATEDmytaMed — Mytamed, Inc.Bausch + Lomb — Bausch & Lomb IncorporatedMicroFrance® — INTEGRA MICROFRANCEBEAR — Mytamed, Inc.AESCULAP — Aesculap AGIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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