American Medical Electronics, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “American Medical Electronics, Inc.” (first 1989, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 250 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 5 | 5 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
| JDQ | Cerclage, Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| JEC | Component, Traction, Invasive | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent American Medical Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951232 | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM | HWC | 1995-08-25 | 158 |
| K952348 | OGDEN ANCHOR | JDR | 1995-08-21 | 94 |
| K950875 | OGDEN ANCHOR | HWC | 1995-07-11 | 133 |
| K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS | HWC | 1995-07-03 | 95 |
| K951493 | OGDEN ANCHOR | HWC | 1995-07-03 | 94 |
| K941029 | OGDEN ANCHOR-SMALL (TENTATIVE) | JDR | 1995-02-09 | 339 |
| K931381 | AME UNIVERSAL FIXATION SYSTEM | KWP | 1995-02-01 | 685 |
| K935065 | OGDEN ANCHOR ADDITIONAL APPLICATIONS | JDR | 1995-01-30 | 467 |
| K942300 | SILKON TITANIUM CABLE SYSTEM | JDQ | 1995-01-09 | 242 |
| K935167 | OGDEN ANCHOR (MODIFICATION) | JDR | 1994-07-12 | 258 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Medical Electronics, 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.
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 Medical Electronics, Inc.?
FDA lists 14 510(k) clearances under the applicant name “American Medical Electronics, Inc.” (first 1989, 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 American Medical Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Medical Electronics, Inc. is 250 days.
Which FDA product codes appear under American Medical Electronics, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 5); JDR (Staple, Fixation, Bone, 4); JDQ (Cerclage, Fixation, 2).
Next steps
- See all 14 American Medical Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, American Medical Electronics, 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.