SonoSite, Inc.
FDA Regulatory Profile
SonoSite, Inc. appears in FDA public data with 1 recall, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0027-2014, Class II) was initiated on September 11, 2013. Its most recent 510(k) clearance was granted on November 15, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0027-2014 | Class II | P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array tran | September 11, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | November 15, 2011 |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | June 3, 2011 |
| K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | November 19, 2010 |
| K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | August 23, 2010 |
| K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | August 12, 2010 |
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | October 2, 2009 |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | August 25, 2008 |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | May 8, 2007 |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | November 16, 2005 |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | August 11, 2005 |
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | January 12, 2005 |
| K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | December 21, 2004 |
| K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L0307 | November 5, 2003 |
| K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | April 7, 2003 |
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | January 22, 2003 |
| K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) | December 12, 2002 |
| K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | May 31, 2002 |
| K014116 | HAND-CARRIED ULTRASOUND SYSTEM | December 20, 2001 |
| K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | February 21, 2001 |
| K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | November 16, 2000 |