Agency for Medical Innovations Inc.
Marblehead, MA, US
AGENCY FOR MEDICAL INNOVATIONS INC. appears in FDA device records in Marblehead, MA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Agency for Medical Innovations Inc. between 2010 and 2021. The busiest year on record is 2010, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212659 | More-Cell-System | PMU | Substantially Equivalent | |
| K182013 | EasyInstruments | GEI | Substantially Equivalent | |
| K182664 | FiXcision | KOA | Substantially Equivalent | |
| K150718 | Wi-3 HAL-RAR System | FHN | Substantially Equivalent | |
| K092821 | TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007153525 | 3007153525 | AGENCY FOR MEDICAL INNOVATIONS INC. | 89 FRONT ST STE 309, MARBLEHEAD, MA 01945 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain