Haemonetics Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeApril 30, 2025
K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMOctober 25, 2012
K120586CELL SAVER ELITEMay 22, 2012
K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMDecember 3, 2010
K062801SMARTSUCTION SOLO DEVICEOctober 4, 2006
K061103HAEMONETICS 40U RBC FILTER BAGMay 17, 2006
K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)November 21, 2005
K052626SMARTSUCTION HARMONY DEVICEOctober 5, 2005
K043127HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEMJanuary 4, 2005
K014083HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEMJanuary 8, 2002
K993581HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTONovember 18, 1999
K953681HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SETJune 4, 1996
K944232AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYSJuly 20, 1995
K932890CELL SAVER 5 SYSTEMJanuary 5, 1994
K904041HAEMONETICS CELL SAVER 4 PLUSNovember 13, 1990
K904474HAEMONETICS LN 200F COLLECTION RESERVOIRNovember 13, 1990
K893394ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAROctober 19, 1989
K883934CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEMDecember 27, 1988
K872895HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.January 11, 1988
K860969FLUID MANAGEMENT SYSTEM (MODIFIED)May 6, 1986