Haag-Streit USA Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0478-2022Class IIOCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4November 3, 2021
Z-0477-2022Class IIOCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4November 3, 2021
Z-1560-2021Class IIEyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.April 15, 2021
Z-0697-2021Class IIHaag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combinNovember 20, 2020
Z-2482-2019Class IIHS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgicalJuly 31, 2019
Z-2483-2019Class IIHS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgicalJuly 31, 2019
Z-2484-2019Class IIHS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgJuly 31, 2019
Z-1500-2017Class IIEyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).January 5, 2017
Z-2411-2012Class IIOctopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine August 17, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYJune 7, 2005