Medical Device Manufacturer · US , Mchenry , IL

Sorin Biomedica, Fiat, USA, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1980

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sorin Biomedica, Fiat, USA, Inc. Cardiovascular ✕

9 devices

1-9 of 9

Cleared May 27, 1994

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS

Cardiovascular · 431d

Cleared May 18, 1993

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

Cardiovascular · 189d

Cleared Mar 26, 1993

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

Cardiovascular · 154d

Cleared Feb 18, 1993

STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR

Cardiovascular · 190d

Cleared Feb 02, 1993

STOCKERT 1/4 BUBBLE SENSOR

Cardiovascular · 91d

Cleared Nov 30, 1992

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

Cardiovascular · 165d

Cleared Jun 24, 1986

S80 IMPLANTABLE CARDIAC PACING LEAD

Cardiovascular · 195d

Cleared Jan 14, 1986

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER

Cardiovascular · 208d

Cleared Dec 03, 1985

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

Cardiovascular · 242d