American Biomaterials Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “American Biomaterials Corp.” (first 1985, latest 1994), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 216 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
Review panels
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Dental (1)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent American Biomaterials Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922455 | EVERT-O-CATH CATHETER | DQO | 1994-07-07 | 776 |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | MDM | 1993-02-05 | 137 |
| K915824 | HOLE PUNCH | FOZ | 1993-01-29 | 396 |
| K880371 | BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER | LYC | 1988-11-18 | 296 |
| K863796 | CREATIVE CARE SYSTEMS' IV START KIT | LRS | 1986-11-28 | 60 |
| K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH | ETA | 1985-01-09 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named American Biomaterials 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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Biomaterials Corp.?
FDA lists 6 510(k) clearances under the applicant name “American Biomaterials Corp.” (first 1985, latest 1994), across 6 product codes in 5 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 American Biomaterials Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Biomaterials Corp. is 216 days.
Which FDA product codes appear under American Biomaterials Corp.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 1); ETA (Replacement, Ossicular Prosthesis, Total, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 6 American Biomaterials Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQO, American Biomaterials 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.