Isoaid, L.L.C.
Port Richey, FL, US
ISOAID, L.L.C. appears in FDA device records in Port Richey, FL. FDA records list 6 510(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 6 510(k) clearances for Isoaid, L.L.C. between 2001 and 2025. The busiest year on record is 2001, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242818 | IsoSphere | KXK | Substantially Equivalent | |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | KXK | Substantially Equivalent | |
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | KXK | Substantially Equivalent | |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | KXK | Substantially Equivalent | |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | KXK | Substantially Equivalent | |
| K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 | KXK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003440305 | 3003440305 | ISOAID, L.L.C. | 7824 CLARK MOODY BLVD., PORT RICHEY, FL 34668 US | 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