Medicult A/S
San Diego, CA, US
Medicult A/S appears in FDA device records in San Diego, CA. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Medicult A/S between 2000 and 2008. The busiest year on record is 2000, with 12. The most recent is 2008, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 12 |
| 2001 | 3 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 | MQL | Substantially Equivalent | |
| K081639 | ICSI CUMULASE | MQL | Substantially Equivalent | |
| K080473 | EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED | MQL | Substantially Equivalent | |
| K061309 | EMBRYOASSIST | MQL | Substantially Equivalent | |
| K061145 | SPERMSLOW | MQL | Substantially Equivalent | |
| K060983 | BIOPSY MEDIUM, MODEL REF 1062 | MQL | Substantially Equivalent | |
| K060699 | SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) | MQL | Substantially Equivalent | |
| K041284 | MEDICULT IVM SYSTEM | MQL | Substantially Equivalent | |
| K030490 | ISM1+, IMS2+, AND UTM+ | MQL | Substantially Equivalent | |
| K031486 | BLASTFREEZE AND BLASTTHAW | MQL | Substantially Equivalent | |
| K031228 | SYNVITRO HYADASE | MQL | Substantially Equivalent | |
| K003404 | SUPRASPERM SYSTEM | MQL | Substantially Equivalent | |
| K003163 | SYNVITRO FLUSH | MQL | Substantially Equivalent | |
| K003156 | BLASTASSIST SYSTEM | MQL | Substantially Equivalent | |
| K991279 | MEDI-CULT UNIVERSAL IVF-MEDIUM | MQL | Substantially Equivalent | |
| K991334 | MEDI-CULT HYALURONIDASE; | MQL | Substantially Equivalent | |
| K991331 | MEDI-CULT M3 MEDIUM | MQL | Substantially Equivalent | |
| K991472 | MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 | MQL | Substantially Equivalent | |
| K991471 | MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) | MQL | Substantially Equivalent | |
| K991332 | MEDI-CULT SPERM PREPARATION - MEDIUM; | MQL | Substantially Equivalent | |
| K991327 | MEDI-CULT FLUSHING MEDIUM | MQL | Substantially Equivalent | |
| K991470 | MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) | MQL | Substantially Equivalent | |
| K991335 | MEDI-CULT FREEZING & THAWING PACKS | MQL | Substantially Equivalent | |
| K991333 | MEDI-CULT SPERM FREEZE MEDIUM | MQL | Substantially Equivalent | |
| K991330 | MEDI-CULT LIQUID PARAFFIN | MQL | Substantially Equivalent | |
| K991329 | MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE | MQL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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