Conmed Integrated Systems (Cmis): FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Conmed Integrated Systems (Cmis)” (first 2003, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 35 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CONMED, based on public ownership records.
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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
Review panels
Most recent Conmed Integrated Systems (Cmis) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091648 | NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 | GCJ | 2009-08-05 | 57 |
| K060717 | NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM | GCJ | 2006-04-25 | 39 |
| K052740 | NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM | GCJ | 2005-10-17 | 17 |
| K050829 | NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM | GCJ | 2005-05-06 | 35 |
| K031979 | CONMED INTEGRATED SYSTEMS NURSES ASSISTANT | FSY | 2003-07-25 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Conmed Integrated Systems (Cmis).
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.
- Conmed Corporation (83 510(k)s)
- Conmed Linvatec (21 510(k)s)
- Conmed Andover Medical, Inc. (8 510(k)s)
- Conmed Endoscopic Technologies, Inc. (2 510(k)s)
- Conmed Corporation, Largo (1 510(k)s)
- Conmed Electrosurgery (1 510(k)s)
- Conmed Integrated Systems, Canada, Ulc (1 510(k)s)
- Conmed Linvatec Biomaterials (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Conmed Integrated Systems (Cmis)?
FDA lists 5 510(k) clearances under the applicant name “Conmed Integrated Systems (Cmis)” (first 2003, latest 2009), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Conmed Integrated Systems (Cmis)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conmed Integrated Systems (Cmis) is 35 days.
Which FDA product codes appear under Conmed Integrated Systems (Cmis)?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); FSY (Light, Surgical, Ceiling Mounted, 1).
Next steps
- See all 5 Conmed Integrated Systems (Cmis) clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Conmed Integrated Systems (Cmis)'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.