Elmed, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Elmed, Inc.” (first 1977, latest 2001), across 15 product codes in 6 review panels. Median 510(k) review time under this name: 87 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 | 7 | 7 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DYC | Vectorcardiograph | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (8)
- Physical Medicine (7)
- Obstetrics and Gynecology (3)
- Cardiovascular (2)
- Neurology (2)
- General Hospital (1)
Most recent Elmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010465 | DENSTAT | GEI | 2001-05-14 | 87 |
| K974793 | ELMED ESU 120 M/M DIGITAL | GEI | 1998-03-19 | 87 |
| K953271 | ELMED RF-ALERT | GEI | 1996-01-18 | 189 |
| K952110 | ELMED THERMO-FLUX | GEI | 1995-08-14 | 101 |
| K926517 | ELMED LBC 50-P | HIN | 1994-11-15 | 685 |
| K932938 | ELMED ESU 300 M/M AND DIGITAL | GEI | 1994-05-02 | 320 |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | GEI | 1993-05-17 | 399 |
| K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | GEI | 1992-11-05 | 321 |
| K905417 | ELMED PNEUMOMAT DIGITAL | HIF | 1991-01-31 | 58 |
| K881431 | SIEMENS STEREODYNATOR 828 | IPF | 1990-04-16 | 741 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elmed, Inc..
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.
- Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi (1 510(k)s)
- Elmed Incorporated (1 510(k)s)
- Elmed USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elmed, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Elmed, Inc.” (first 1977, latest 2001), across 15 product codes in 6 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 Elmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elmed, Inc. is 87 days.
Which FDA product codes appear under Elmed, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); IPF (Stimulator, Muscle, Powered, 3); IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, 2).
Next steps
- See all 26 Elmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Elmed, Inc.'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.