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Abbott Medical Optics, Inc.

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Out recall (Z-1515-2015)Abbott Medical Optics, Inc.2015-04-23
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactu recall (Z-0046-2014)Abbott Medical Optics, Inc.2013-10-22
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product i recall (Z-0047-2014)Abbott Medical Optics, Inc.2013-10-22
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 003 recall (Z-0048-2014)Abbott Medical Optics, Inc.2013-10-22
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufac recall (Z-0049-2014)Abbott Medical Optics, Inc.2013-10-22
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is recall (Z-1670-2013)Abbott Medical Optics, Inc.2013-07-09
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonw recall (Z-1539-2013)Abbott Medical Optics, Inc.2013-06-13
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, recall (Z-1540-2013)Abbott Medical Optics, Inc.2013-06-13
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Dr recall (Z-1541-2013)Abbott Medical Optics, Inc.2013-06-13

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