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Acist Medical Systems

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Cathete recall (Z-1161-2021)Acist Medical Systems2021-03-04
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) recall (Z-0744-2016)Acist Medical Systems2016-02-02
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used recall (Z-1145-2013)Acist Medical Systems2013-04-18
ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, recall (Z-1872-2009)Acist Medical Systems2009-08-30
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiov recall (Z-0643-2009)Acist Medical Systems2009-01-08
ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical recall (Z-2406-2008)Acist Medical Systems2008-09-23
ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured recall (Z-0359-2008)Acist Medical Systems2007-12-08
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management S recall (Z-1002-04)Acist Medical Systems2004-07-20
ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Cont recall (Z-0064-04)Acist Medical Systems2003-10-24

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