Medical Device Manufacturer · US , North Attleboro , MA

Carl Zeiss Surgical GmbH - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

Recent clearances: INTRABEAM NEEDLE APPLICATOR, ZEISS INFRARED 800 WITH FLOW 800 OPTION, INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Carl Zeiss Surgical GmbH Radiology ✕

4 devices

1-4 of 4

Cleared Apr 13, 2012

INTRABEAM NEEDLE APPLICATOR

Radiology · 408d

Cleared Mar 03, 2010

ZEISS INFRARED 800 WITH FLOW 800 OPTION

Radiology · 13d

Cleared Nov 24, 2009

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS

Radiology · 266d

Cleared May 23, 2005

INTRABEAM SYSTEM

Radiology · 27d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026