Medical Device Manufacturer · US , Austin , TX

Radiadyne - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2009
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Radiadyne Radiology ✕
3 devices
1-3 of 3
Cleared Jul 22, 2014
OARTRAC SYSTEM
K141154 · NZT
Radiology · 78d
Not Cleared Jan 28, 2014
PROSTATE IMMOBILIZER RECTAL BALLOON
DEN130036 · PCT
Radiology · 197d
Cleared Dec 07, 2009
ALATUS VAGINAL BALLOON PACKING SYSTEM
K092534 · JAQ
Radiology · 110d
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