Medical Device Manufacturer · US , Pinellas Park , FL

Burkhart Roentgen Intl., Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1992

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Burkhart Roentgen Intl., Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Jun 30, 1992

ORWO X-RAY FILM

Radiology · 146d

Cleared May 29, 1992

PROTECTIVE RADIOGRAFIC GLOVE

Radiology · 114d

Cleared May 28, 1992

RADIOLOGICAL PROTECTIVE EYE SHIELD

Radiology · 113d