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Carbomedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970375ANNULOFLO SYSTEMJuly 25, 1997
K964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)February 19, 1997
K962154CARBOMEDICS HANDLEAugust 27, 1996
K960923CARBOMEDICS MITRAL ROTATORApril 29, 1996
K960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTApril 25, 1996
K960169CARBOMEDICS VALVE TESTERApril 15, 1996
K955588VASCUTEK GRAFT SIZER SETMarch 7, 1996
K952184CARBOMEDICS SUPRA-ANNULAR VALVE SIZERNovember 29, 1995
K951368CARBOMEDICS EXENDED MITRAL ROTATORJune 20, 1995
K942736CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLEJuly 6, 1994
K934951VALVE SIZERDecember 10, 1993
K842893DORR HIP PROSTHESIS, ACETABULAR COMPONNovember 8, 1984
K842360DORR HIP PROSTHESIS FEMORAL COMPONENTOctober 2, 1984
K833404BDH BIPOLAR FEMORAL COMPONENT A3March 2, 1984
K834040MINATURE PRESSURE TRANSDUCERFebruary 10, 1984
K833403BDH UNIPOLAR FEMORAL COMPONENT A2January 10, 1984
K833468BDH UNIVERSAL HIP SYSTEM SURGEONDecember 27, 1983
K811101HYDROXYLAPATITENovember 20, 1981
K810382HYDROXYLAPATITE ALVEOLAR RIDGE MAINMarch 20, 1981
K791416PYROLITE CARBON ALVEOLAR MAINTEN IMPLANTOctober 9, 1979