Nidacon International AB
MOLNDAL Vastra Gotaland, SE
NIDACON INTERNATIONAL AB appears in FDA device records in MOLNDAL Vastra Gotaland, SE. FDA records list 12 510(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 12 510(k) clearances for Nidacon International AB between 1998 and 2014. The busiest year on record is 2001, with 4. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 2 |
| 2010 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131145 | PROINSERT | MQK | Substantially Equivalent | |
| K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | MQL | Substantially Equivalent | |
| K023206 | SPERM CRYOPROTEC | MQL | Substantially Equivalent | |
| K022443 | SPERMASSIST | MQL | Substantially Equivalent | |
| K011607 | SPERMCATCH | MQL | Substantially Equivalent | |
| K012123 | NIDOIL | MQL | Substantially Equivalent | |
| K011606 | PURESPERM BUFFER | MQL | Substantially Equivalent | |
| K011346 | READYSWIM | MQL | Substantially Equivalent | |
| K002630 | PURESPERM WASH | MQL | Substantially Equivalent | |
| K002623 | PURESPERM 40 AND PURESPERM 80 | MQL | Substantially Equivalent | |
| K984172 | MODIFICATION OF PURESPERM | MQL | Substantially Equivalent | |
| K980814 | PURESPERM | MQL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616005 | 3004848623 | NIDACON INTERNATIONAL AB | FLOJELBERGSGATAN 16B, MOLNDAL Vastra Gotaland SE-431 37 SE | 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