Home › Device types › MIB
Elastomer, Silicone Block
FDA product code MIB · Class 2 · Ear, Nose, Throat
1,037
Registered devices
187
Adverse events
3
Recalls
45
510(k) clearances
Devices with this code
Silicone Carving Block — Hanson Medical, Inc.Calf Implant — Hanson Medical, Inc.AART Silicone Carving Block — AartAART Silicone Carving Block Sizer — AartSilicone Carving Block — Hanson Medical, Inc.AART Gluteal Implant Sizer — AartSilicone Carving Block — Hanson Medical, Inc.Gluteal Implant — AartSpectrum Designs Medical — SPECTRUM DESIGNS INCAART Gluteal Implant — AartTechnical Products — TECHNICAL PRODUCTS INCAlliedSil™ Sheeting — IMPLANTECH ASSOCIATES, INC.Technical Products — TECHNICAL PRODUCTS INCAART Gluteal Implant Sizer — AartAART Calf Implant — AartAART Calf Implant — AartSpectrum Designs Medical — SPECTRUM DESIGNS INCContourFlex™ Gluteal Implant Sizer — IMPLANTECH ASSOCIATES, INC.Himplant Pre-Formed Penile Silicone Block — INTERNATIONAL MEDICAL DEVICES, INC.Himplant Pre-Formed Penile Silicone Block — INTERNATIONAL MEDICAL DEVICES, INC.Contoured Carving Block Style 10 — IMPLANTECH ASSOCIATES, INC.SIENTRA Gluteal Implant — Sientra, Inc.Rectangular Carving Block 1.0 — IMPLANTECH ASSOCIATES, INC.AlliedSil™ Sheeting — IMPLANTECH ASSOCIATES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| 2025-09-26 | DSAART LLC | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
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