Medical Device Manufacturer · US , Mchenry , IL

Burditt & Calkins-Siemens-Elema - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1976

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Burditt & Calkins-Siemens-Elema Cardiovascular ✕

5 devices

1-5 of 5

Cleared Jan 30, 1984

PULSE GENERATOR MODEL 688

Cardiovascular · 111d

Cleared Jan 26, 1984

RAYDEN MEDICAL MINI PULSE VOLUME RECORD

Cardiovascular · 133d

Cleared May 27, 1983

SIEMENS-ELMA PULSE GENERATOR #718

Cardiovascular · 114d

Cleared Dec 30, 1982

MON-A-THERM MYOCARDIAL TEMP. SENSOR

Cardiovascular · 44d

Cleared Oct 04, 1982

COAXIAL BIPOLAR PACING ELECTRODE

Cardiovascular · 68d