MEDART ApS
HVIDOVRE Hovedstaden, DK
MEDART ApS appears in FDA device records in HVIDOVRE Hovedstaden, DK. FDA records list 8 510(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 8 510(k) clearances for MEDART ApS between 1999 and 2012. The busiest year on record is 1999, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120573 | MEDART 620 | GEX | Substantially Equivalent | |
| K110243 | MEDART DIODE LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K083123 | MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K010885 | UNI-LASER 470 | GEX | Substantially Equivalent | |
| K000503 | MEDART 520 COOLING SYSTEM | GEX | Substantially Equivalent | |
| K993815 | UNI-LASER 430 | GEX | Substantially Equivalent | |
| K991659 | UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K991297 | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021543 | 3005616124 | MEDART ApS | Industriparken 22a, Ballerup 2750 DK | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain