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Panels › Ophthalmic › Product code HJB · Class 1

Instrument, Measuring, Corneal Radius

Regulation 886.1450

0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in HJB

Company510(k)sRecalls
Haag-Streit USA Inc02
Acufex Microsurgical, Inc.10
Heidelberg Instruments10
Kera Corp.10
Marco Ophthalmic, Inc.10
R.H. Burton Co.10
DateFirm and productCodeLinked 510(k)
Jan 11, 2012Haag-Streit USA Inc
Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product
Terminated
HJBNone listed
Aug 9, 2011Haag-Streit USA Inc
Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer)
Terminated
HJBK082891

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