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Sorin Biomedica, Fiat, USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORSMay 27, 1994
K925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULEMay 18, 1993
K925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSMarch 26, 1993
K925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEMarch 26, 1993
K924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORFebruary 18, 1993
K925541STOCKERT 1/4 BUBBLE SENSORFebruary 2, 1993
K922933SORIN MONOLYRH INTEGRATED MEMBRANE LUNGNovember 30, 1992
K854963S80 IMPLANTABLE CARDIAC PACING LEADJune 24, 1986
K852641ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMERJanuary 14, 1986
K851365SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PMDecember 3, 1985
K841947ESTRADIOL DIRECT RADIOIMMUNOASSAY KITJune 25, 1984
K841948TESTOSTERONE DIRECT RADIOIMMUNOASSAYJune 25, 1984
K841573INSULIN RADIOIMMUNOASSAY KITMay 16, 1984
K832694DIRIA-PROGK IMMUNOASSAYJanuary 11, 1984
K833768C. PTH RADIOIMMUNOASSAY KIT-CPTHKDecember 29, 1983
K830563CORTISOL RADIOIMMUNOASSAY KIT-CORTCTKMay 13, 1983
K800773DIGOCTK 125April 24, 1980
K800775ALDOCTK-125April 21, 1980
K800776TESTOK-125April 21, 1980
K800774RENCTKApril 21, 1980