Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1988

145

Total

145

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heraeus Kulzer, Inc. Radiology ✕

6 devices

1-6 of 6

Cleared Jan 05, 1994

Radiology · 119d

Cleared Dec 14, 1993

Radiology · 67d

Cleared Nov 03, 1993

Radiology · 114d

Cleared Jul 20, 1993

Radiology · 230d

Cleared May 20, 1993

PMI100 VIDEO IMAGER

Radiology · 216d

Cleared Apr 08, 1993

MATRIX CR 2050, PMI 3000

Radiology · 169d