Applied Medical: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Applied Medical” (first 1985, latest 2021), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 122 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 | 1 | 35 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 292 |
| 2021 | 1 | 448 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Applied Medical took a median 370 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DRC | Trocar | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FHF | System, Evacuator, Fluid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Applied Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202818 | Voyant Fine Fusion Device (EB230) | GEI | 2021-12-16 | 448 |
| K191866 | GelPOINT Mini Advanced Access Platform | GCJ | 2020-04-29 | 292 |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | BTA | 2012-10-02 | 35 |
| K070865 | EXPANDING VASCULAR SHEATH | DYB | 2007-10-23 | 208 |
| K003443 | SUCTION IRRIGATOR | FHF | 2001-02-01 | 87 |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | DXC | 2001-01-08 | 112 |
| K915826 | BIO-POLAR FORCEPS | GEI | 1992-06-02 | 155 |
| K911462 | SURGICAL TROCAR | DRC | 1991-04-22 | 19 |
| K844726 | GAUZE SPONGE 4X4X12 PLY | EFQ | 1985-04-01 | 118 |
| K844677 | APPLIED GAUZE SPONGE 2X2X12 | EFQ | 1985-04-01 | 122 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Medical.
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 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?
FDA lists 14 510(k) clearances under the applicant name “Applied Medical” (first 1985, latest 2021), across 8 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Medical is 122 days.
Which FDA product codes appear under Applied Medical?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 14 Applied Medical clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Applied Medical'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.