Medical Device Manufacturer · US , Annapolis , MD

Ziehm International, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1982

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ziehm International, Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Oct 14, 1983

CARDIAC OUTPUT COMPUTER

Cardiovascular · 165d

Cleared Oct 15, 1982

BIPOLAR TEMP. PACING CATHETER W/STYLETET

Cardiovascular · 99d

Cleared Oct 15, 1982

BALLOON TEMP. PACING CATHETER

Cardiovascular · 99d

Cleared Aug 24, 1982

BERMAN ANGIOGRAPHIC BALLOON CATHETER

Cardiovascular · 43d

Cleared Aug 24, 1982

BALLOON WEDGE PRESSURE CATHETER

Cardiovascular · 43d