SonoSite, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0027-2014Class IIP21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array tranSeptember 11, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K113156SONOSITE EDGE ULTRASOUND SYSTEMNovember 15, 2011
K110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORJune 3, 2011
K102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMNovember 19, 2010
K093510LUMENVU CATHETER GUIDANCE SYSTEMAugust 23, 2010
K101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEMAugust 12, 2010
K092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMOctober 2, 2009
K082098SONOSITE MAXX SERIES ULTRASOUND SYSTEMAugust 25, 2008
K071134SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEMMay 8, 2007
K053069SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)November 16, 2005
K052109SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)August 11, 2005
K043559SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)January 12, 2005
K043452TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEMDecember 21, 2004
K033367TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L0307November 5, 2003
K030949TITAN HIGH RESOLUTION ULTRASOUND SYSTEMApril 7, 2003
K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYJanuary 22, 2003
K023957SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)December 12, 2002
K021628SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)May 31, 2002
K014116HAND-CARRIED ULTRASOUND SYSTEMDecember 20, 2001
K010374SONOSITE HAND-CARRIED ULTRASOUND SYSTEMFebruary 21, 2001
K003399SONOSITE HAND-CARRIED ULTRASOUND SYSTEMNovember 16, 2000