Applied Medical
Rancho Santa, CA, US
Applied Medical appears in FDA device records in Rancho Santa, CA. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Applied Medical between 1985 and 2021. The busiest year on record is 1985, with 6. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 6 |
| 1991 | 1 |
| 1992 | 1 |
| 2001 | 2 |
| 2007 | 1 |
| 2012 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202818 | Voyant Fine Fusion Device (EB230) | GEI | Substantially Equivalent | |
| K191866 | GelPOINT Mini Advanced Access Platform | GCJ | Substantially Equivalent | |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | BTA | Substantially Equivalent | |
| K070865 | EXPANDING VASCULAR SHEATH | DYB | Substantially Equivalent | |
| K003443 | SUCTION IRRIGATOR | FHF | Substantially Equivalent | |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | DXC | Substantially Equivalent | |
| K915826 | BIO-POLAR FORCEPS | GEI | Substantially Equivalent | |
| K911462 | SURGICAL TROCAR | DRC | Substantially Equivalent | |
| K844726 | GAUZE SPONGE 4X4X12 PLY | EFQ | Substantially Equivalent | |
| K844677 | APPLIED GAUZE SPONGE 2X2X12 | EFQ | Substantially Equivalent | |
| K844676 | APPLIED GAUZE SPONGE 4X4X8 | EFQ | Substantially Equivalent | |
| K844675 | APPLIED GAUZE SPONGE 3X3X12 | EFQ | Substantially Equivalent | |
| K844674 | APPLIED GAUZE SPONGE 2X2X8 PLY | EFQ | Substantially Equivalent | |
| K844673 | APPLIED GAUZE SPONGE 4X4X16 PLY | EFQ | 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
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain