Numed Technologies, Inc.: FDA clearances and approvals
Numed Technologies, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time: 362 days.
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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 1 | 1 |
Review panels
Most recent Numed Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922248 | MALLAWANY ATRAUMATIC TISSUE FORCEPS | HET | 1994-02-17 | 645 |
| K930571 | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | HFI | 1994-02-01 | 362 |
| K931501 | NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST. | HET | 1994-01-11 | 292 |
| K923126 | MALLAWANY TISSUE GRASPING FORCEPS | HET | 1993-10-08 | 469 |
| K923055 | OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES | GCJ | 1992-11-23 | 152 |
Recalls
openFDA lists no recalls under a recalling firm named Numed Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Numed Technologies, Inc. have?
Numed Technologies, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1994), across 3 product codes in 2 review panels.
How long does FDA take to clear Numed Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Numed Technologies, Inc.'s cleared 510(k)s is 362 days.
What devices does Numed Technologies, Inc. make?
Its most frequent FDA product codes are HET (Laparoscope, Gynecologic (And Accessories), 3); GCJ (Laparoscope, General & Plastic Surgery, 1); HFI (Coagulator, Culdoscopic (And Accessories), 1).
Has Numed Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Numed Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Numed Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, Numed Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.