Modern Medical Equipment Mfg., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Modern Medical Equipment Mfg., Ltd.” (first 2003, latest 2010), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 232 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| FHF | System, Evacuator, Fluid | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Review panels
- General and Plastic Surgery (9)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Ophthalmic (1)
Most recent Modern Medical Equipment Mfg., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093479 | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | FHF | 2010-05-19 | 191 |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | FAS | 2010-01-15 | 238 |
| K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT | GEI | 2007-09-14 | 172 |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | HGI | 2007-07-27 | 120 |
| K050842 | AGCEL WOUND DRESSING,AGCEL BURN DRESSING | FRO | 2006-08-02 | 488 |
| K043036 | NON-STICK ELECTRODE | GEI | 2005-05-06 | 183 |
| K033095 | SMOKE EVACUATION ATTACHEMENT | GEI | 2004-11-17 | 415 |
| K040238 | SOFTSEAL HSG CATHETER | LKF | 2004-06-22 | 148 |
| K032327 | MODERN MEDICAL BIPOLAR FORCEPS | GEI | 2004-06-15 | 323 |
| K030831 | LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS | GEI | 2004-06-15 | 459 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Modern Medical Equipment Mfg., Ltd..
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.
- Modern Diagnostics, Inc. (5 510(k)s)
- Modern Rubber Industrial Co., Ltd. (5 510(k)s)
- Modern Medical Equipment Manufacturing, Ltd. (4 510(k)s)
- Modern Medical Equipment Manufacturing Limited (4 510(k)s)
- Modern Healthcare Corp. (3 510(k)s)
- Modern Dental Laboratory (Dg) Co., Ltd. (2 510(k)s)
- Modern Engineering Co., Inc. (2 510(k)s)
- Modern Materials (2 510(k)s)
- Modern Medical Systems Co. (2 510(k)s)
- Modern Systems Technology, Inc. (2 510(k)s)
- Modern Health Care Products (1 510(k)s)
- Modern Korea Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Modern Medical Equipment Mfg., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Modern Medical Equipment Mfg., Ltd.” (first 2003, latest 2010), across 7 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 Modern Medical Equipment Mfg., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Modern Medical Equipment Mfg., Ltd. is 232 days.
Which FDA product codes appear under Modern Medical Equipment Mfg., Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); FAS (Electrode, Electrosurgical, Active, Urological, 1); FHF (System, Evacuator, Fluid, 1).
Next steps
- See all 14 Modern Medical Equipment Mfg., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Modern Medical Equipment Mfg., 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.