MIC
8 FDA 510(k) clearances · Product code
73 daysmedian time to decision
165 days90th percentile
8clearances measured
FDA profile
- Official device name
- Implant, Muscle, Pectoralis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AART PECTORALIS IMPLANT (K021337) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-03 |
| SILMAX PECTORAL IMPLANT (K002633) | Pillar Surgical, Inc. | 2000-11-21 |
| SEARE BIOMEDICAL PECTORALIS IMPLANT (K982762) | Seare Biomedical Corp. | 1998-09-30 |
| SEARE BIOMEDICAL SILICONE BLOCK (K983043) | Seare Biomedical Corp. | 1998-09-30 |
| POWERFLEX PEC IMPLANT (K973729) | Hanson Medical, Inc. | 1997-12-24 |
| PEC IMPLANT (K961072) | Rand Scientific Corp. | 1996-04-19 |
| SPECTRUM DISIGNS PECTORAL IMPLANT (K944163) | Spectrum Designs, Inc. | 1994-11-07 |
| PEC IMPLANT (K913768) | Applied Biomaterial Technologies | 1992-02-03 |
Track MIC automatically
Every clearance here is in the API, with alerts when new ones post.