T.A.G. Medical Products Corporation, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “T.A.G. Medical Products Corporation, Ltd.” (first 2011, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 101 days, against 120 days for all cleared 510(k)s in the same product codes. 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 | 115 |
| 2013 | 0 | — |
| 2014 | 1 | 28 |
| 2015 | 1 | 175 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 111 |
| 2020 | 1 | 101 |
| 2021 | 1 | 30 |
| 2022 | 1 | 84 |
| 2023 | 2 | 95 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 245 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name T.A.G. Medical Products Corporation, Ltd. took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
Review panels
- Orthopedic (9)
- General and Plastic Surgery (2)
- Dental (1)
Most recent T.A.G. Medical Products Corporation, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253858 | GFS - Sterile Screws and Top Hat | HWC | 2026-08-05 | 245 |
| K231400 | Bladeless Trocar Artemis Lap Cannula | GCJ | 2023-08-04 | 81 |
| K230058 | Bladeless Trocar Artemis Lap Cannula | GCJ | 2023-04-28 | 109 |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | 2022-09-07 | 84 |
| K210498 | Betta Link Knotless Implant System | MBI | 2021-03-24 | 30 |
| K202178 | VersaLoop Anchor System | MBI | 2020-11-13 | 101 |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | 2019-05-19 | 111 |
| K143326 | T.A.G. Dental Implant System | DZE | 2015-05-14 | 175 |
| K142653 | G-Lok and G-Lok XL Extender | MBI | 2014-10-16 | 28 |
| K113297 | KNOTILUS ANCHOR SYSTEM | MBI | 2012-03-02 | 115 |
2 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 2 recall events; 6 initiated in the last five years. Most recent: 2023-05-04.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under T.A.G. Medical Products Corporation, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “T.A.G. Medical Products Corporation, Ltd.” (first 2011, latest 2026), across 4 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 T.A.G. Medical Products Corporation, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name T.A.G. Medical Products Corporation, Ltd. is 105 days. Since 2017: 101 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under T.A.G. Medical Products Corporation, Ltd.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 7); GCJ (Laparoscope, General & Plastic Surgery, 2); HWC (Screw, Fixation, Bone, 2).
Next steps
- See all 12 T.A.G. Medical Products Corporation, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MBI, T.A.G. Medical Products Corporation, Ltd.'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.