Optomed
Oulu Pohjois-Pohjanmaa, FI
Optomed appears in FDA device records in Oulu Pohjois-Pohjanmaa, FI. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Optomed between 1993 and 2018. The busiest year on record is 1993, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1999 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | HKI | Substantially Equivalent | |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | HKI | Substantially Equivalent | |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | HKI | Substantially Equivalent | |
| K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | HKI | Substantially Equivalent | |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | HKI | Substantially Equivalent | |
| K990417 | DERMACOOL | GEX | Substantially Equivalent | |
| K923531 | OPTOSCALPEL I LASER SYSTEM | HQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007710608 | 3007710608 | Optomed | Yrttipellontie 1, Oulu Pohjois-Pohjanmaa 90230 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Optomed edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain