Applied Biomaterial Technologies: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Applied Biomaterial Technologies” (first 1990, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| MIB | Elastomer, Silicone Block | 2 | 2 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Applied Biomaterial Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945552 | DURALASTIC SHEETING | MIB | 1995-01-31 | 82 |
| K935571 | DURALASTIC SHEETING | MIB | 1995-01-31 | 439 |
| K931500 | THE PERMARIDGE MATRIX CHIN | FWP | 1994-11-17 | 602 |
| K913768 | PEC IMPLANT | MIC | 1992-02-03 | 165 |
| K902285 | THE MAGNUM CHIN IMPLANT | FWP | 1990-09-12 | 113 |
| K902284 | ZYMALAR IMPLANT | LZK | 1990-09-12 | 113 |
| K902283 | THE NAUTILUS NASAL IMPLANT | FZE | 1990-08-14 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Biomaterial Technologies.
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.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Biomaterial Technologies?
FDA lists 7 510(k) clearances under the applicant name “Applied Biomaterial Technologies” (first 1990, latest 1995), across 5 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 Applied Biomaterial Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Biomaterial Technologies is 113 days.
Which FDA product codes appear under Applied Biomaterial Technologies?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 2); MIB (Elastomer, Silicone Block, 2); FZE (Prosthesis, Nose, Internal, 1).
Next steps
- See all 7 Applied Biomaterial Technologies clearances with predicates and recalls
- Run predicate analysis for product code FWP, Applied Biomaterial Technologies'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.