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SonoSite, Inc.

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased arra recall (Z-0027-2014)SonoSite, Inc.2013-10-18
MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound recall (Z-0057-2012)Sonosite, Inc.2011-10-18
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is use recall (Z-0478-2011)Sonosite, Inc.2010-11-26
Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultr recall (Z-2654-2010)Sonosite, Inc.2010-10-01
SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer lab recall (Z-2655-2010)Sonosite, Inc.2010-10-01
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Dri recall (Z-2191-2010)Sonosite, Inc.2010-08-09
PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the st recall (Z-2116-2010)Sonosite, Inc.2010-08-02
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer recall (Z-0661-2007)Sonosite, Inc.2007-03-29
SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resol recall (Z-0713-06)Sonosite, Inc.2006-04-06
SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite recall (Z-0407-06)Sonosite, Inc.2006-01-19

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Every clearance here is in the API, with alerts when new ones post.