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AMO Manufacturing USA, LLC

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20 recall (Z-0165-2012)AMO Manufacturing USA, LLC2011-11-04
Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20 recall (Z-0166-2012)AMO Manufacturing USA, LLC2011-11-04
Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; P recall (Z-0167-2012)AMO Manufacturing USA, LLC2011-11-04
STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC recall (Z-2965-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA, LLC recall (Z-2966-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.02 Mfg by : AMO Manufacturing USA, LLC recall (Z-2967-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.10 Mfg by : AMO Manufacturing USA, LLC recall (Z-2968-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC recall (Z-2969-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC recall (Z-2970-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC recall (Z-2971-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.20 Mfg by : AMO Manufacturing USA, LLC recall (Z-2972-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC recall (Z-2973-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC recall (Z-2974-2011)AMO Manufacturing USA, LLC2011-08-09
STAR S4 IR Excimer Laser System; Software Version 5.30 Mfg by : AMO Manufacturing USA, LLC recall (Z-2975-2011)AMO Manufacturing USA, LLC2011-08-09
AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 007 recall (Z-1374-2011)AMO Manufacturing USA, LLC2011-02-18

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