Medishield, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medishield, Inc.” (first 1976, latest 1978), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 12 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 | 1 |
| DAT | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDY | Evacuator, Vapor, Cement Monomer | 1 | 1 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 1 | 1 |
Review panels
- Orthopedic (5)
- Anesthesiology (1)
- Dental (1)
- Hematology (1)
Most recent Medishield, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781103 | SPECTRASCAN | DAT | 1978-09-27 | 86 |
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | KIJ | 1978-05-03 | 16 |
| K780646 | AIR-PWOERED COLDRILL | EKX | 1978-04-28 | 11 |
| K780202 | MONOMER EVACUATION SYSTEM | JDY | 1978-02-21 | 14 |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | JDG | 1977-01-26 | 2 |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | HSN | 1976-11-23 | 12 |
| K761020 | ANKLE (FREEMAN-SWANSON) | HSN | 1976-11-23 | 12 |
| K760668 | SELECTATEC SYSTEM | CAD | 1976-09-27 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Medishield, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medishield, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Medishield, Inc.” (first 1976, latest 1978), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medishield, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medishield, Inc. is 12 days.
Which FDA product codes appear under Medishield, Inc.?
The most frequent FDA product codes under this applicant name are HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, 2); CAD (Vaporizer, Anesthesia, Non-Heated, 1); DAT (Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control, 1).
Next steps
- See all 8 Medishield, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSN, Medishield, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.