Allied Biomedical Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Allied Biomedical Corp.” (first 1995, latest 1998), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | 3 | 3 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| KGZ | Accessories, Catheter | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
Review panels
Most recent Allied Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982051 | KELOCATE SHEETING | MDA | 1998-08-05 | 55 |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | FZE | 1997-07-18 | 86 |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | LZK | 1997-07-18 | 86 |
| K971478 | DURALASTIC ANATOMICAL CHIN IMPLANTS | FWP | 1997-07-18 | 86 |
| K971480 | DURALASTIC I AND DURALASTIC II | MIB | 1997-05-28 | 35 |
| K955370 | DURALASTIC II | MIB | 1996-02-08 | 78 |
| K955368 | DURALASTIC I | MIB | 1996-02-08 | 78 |
| K955433 | DURALASTIC SILICONE TUBING | KGZ | 1996-01-26 | 59 |
| K954413 | KELOCOTE | MDA | 1995-11-29 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Allied Biomedical Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Allied Healthcare Products, Inc. (26 510(k)s)
- Allied Associates, Inc. (9 510(k)s)
- Allied Instrumentation Laboratory (7 510(k)s)
- Allied Rubber Industries Sdn. Bhd. (2 510(k)s)
- Allied Signal, Inc. (2 510(k)s)
- Allied Advanced Technologies (Aat) (1 510(k)s)
- Allied Dental Solutions (1 510(k)s)
- Allied Fisher Scientific (1 510(k)s)
- Allied Hill Enterprises, Ltd. (1 510(k)s)
- Allied Medical Technologies, Inc. (1 510(k)s)
- Allied Photo Products Co., Inc. (1 510(k)s)
- Allied Systems Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Allied Biomedical Corp.?
FDA lists 9 510(k) clearances under the applicant name “Allied Biomedical Corp.” (first 1995, latest 1998), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Allied Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allied Biomedical Corp. is 78 days.
Which FDA product codes appear under Allied Biomedical Corp.?
The most frequent FDA product codes under this applicant name are MIB (Elastomer, Silicone Block, 3); MDA (Elastomer, Silicone, For Scar Management, 2); FWP (Prosthesis, Chin, Internal, 1).
Next steps
- See all 9 Allied Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code MIB, Allied Biomedical Corp.'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.