Medical Device Manufacturer · US , Coral Gables , FL

Elekta Implants, SA - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1998

Recent clearances: SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER, PRECISION FLOW OSV II

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elekta Implants, SA Neurology ✕

2 devices

1-2 of 2

Cleared Mar 18, 1998

SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER

Neurology · 90d

Cleared Feb 06, 1998

PRECISION FLOW OSV II

Neurology · 267d