Applied Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Applied Medical Devices, Inc.” (first 1979, latest 1984), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (3)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- Hematology (1)
- Radiology (1)
Most recent Applied Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843885 | PERCUTANEOUS ASPIRATION BIOPSY TRAY | — | 1984-12-19 | 78 |
| K843884 | GENERAL UTILITY TRAY SYSTEM | — | 1984-12-13 | 72 |
| K843883 | STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN | — | 1984-12-13 | 72 |
| K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST | KHE | 1984-08-16 | 170 |
| K842591 | ULTRASOUND PROBE COVERS-STERILE | IYO | 1984-07-23 | 20 |
| K833720 | TRANSTHORACIC/TRANSABDOMINAL-TRAY | GDM | 1984-05-30 | 219 |
| K840334 | CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY | FMI | 1984-04-13 | 79 |
| K833438 | PREPACELL-STERILE-BONE MARROW ASPIR | KDD | 1984-02-09 | 127 |
| K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY | KOD | 1984-01-25 | 93 |
| K802406 | CYTOTRAN I BONE MARROW ASPIRATION SYSTEM | FMF | 1981-01-15 | 104 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Medical Devices, 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.
- 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 Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Medical Devices, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Applied Medical Devices, Inc.” (first 1979, latest 1984), across 8 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 Applied Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Medical Devices, Inc. is 79 days.
Which FDA product codes appear under Applied Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 1); GDM (Needle, Aspiration And Injection, Reusable, 1).
Next steps
- See all 11 Applied Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Applied Medical Devices, 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.