Applied Medical Research: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Applied Medical Research” (first 1977, latest 1980), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 10 | 10 |
| DSK | Computer, Blood-Pressure | 5 | 5 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
| FSH | Tray, Surgical, Needle | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
Review panels
- Cardiovascular (18)
- Neurology (2)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Applied Medical Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800025 | DINAMAP RESEARCH MONITOR 1245 | DXN | 1980-02-01 | 25 |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | OMA | 1979-09-04 | 18 |
| K791159 | DINAMAP MODEL 855 | DXN | 1979-07-30 | 39 |
| K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | EBW | 1979-05-14 | 88 |
| K790328 | MODEL 1051, MONITOR | DXN | 1979-03-02 | 14 |
| K782073 | DINAMAP MODELS 1160 AND 1165 | DSK | 1979-02-23 | 72 |
| K781064 | DINAMAP MODEL 848 | DSK | 1978-09-07 | 73 |
| K781053 | DINAMAP MODEL 846 | DSK | 1978-09-07 | 77 |
| K781311 | ELECTRODE, NEEDLE, CFM | GXZ | 1978-08-21 | 21 |
| K780754 | NEONATAL MONITOR | DXN | 1978-06-14 | 36 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Medical Research.
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 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 Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
- Applied Polytechnology, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Medical Research?
FDA lists 22 510(k) clearances under the applicant name “Applied Medical Research” (first 1977, latest 1980), across 8 product codes in 4 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 Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Medical Research is 20 days.
Which FDA product codes appear under Applied Medical Research?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 10); DSK (Computer, Blood-Pressure, 5); DRS (Transducer, Blood-Pressure, Extravascular, 2).
Next steps
- See all 22 Applied Medical Research clearances with predicates and recalls
- Run predicate analysis for product code DXN, Applied Medical Research'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.