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File, Bone, Surgical
FDA product code EMI · Class 1 · Dental
335
Registered devices
0
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
Mx-Grafter — MAXILON LABORATORIES INCNAIL RASPATORY — SONTEC INSTRUMENTS, INC.Marina Medical — MARINA MEDICAL INSTRUMENTS, INC.ebner 502 Handle 30 degree Up Head Angle — MAXILON LABORATORIES INCOSUNG MND — OSUNG MND Co., Ltd.Reicodent — devemed GmbHHU-FRIEDY — HU-FRIEDY MFG. CO., LLCHU-FRIEDY — HU-FRIEDY MFG. CO., LLCZOLL-DENTAL — Zoll-DentalSTOMA® — Storz am Mark GmbHReicodent — devemed GmbHARKANSAS HARD SHARPENER — SONTEC INSTRUMENTS, INC.DentaSonic — Gc Orthodontics America Inc.V. Mueller — CAREFUSION 2200, INCFILE — KLS-Martin L.P.Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCFILE — KLS-Martin L.P.DentaSonic — Gc Orthodontics America Inc.Ambler Surgical — AMBLER SURGICAL CORP.Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INCBONE FILE #52X CROSS CUT HD D/E DLC — W.H. Holden, Inc.gSource — GSOURCE LLCV. Mueller — STERIS CORPORATIONReicodent — devemed GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-26 | Meta C.G.M. Spa | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized |
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