Medical Device Manufacturer · US , Port Richey , FL

Isoaid, LLC - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2004

Recent clearances: IsoSphere, I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE], ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Isoaid, LLC Radiology ✕

5 devices

1-5 of 5

Cleared Jul 15, 2025

Radiology · 300d

Cleared Dec 05, 2014

I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]

Radiology · 164d

Cleared Aug 10, 2012

ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT

Radiology · 283d

Cleared Sep 15, 2009

ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

Radiology · 151d

Cleared Apr 08, 2004

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

Radiology · 127d