Haag-Streit USA Inc
FDA Regulatory Profile
Haag-Streit USA Inc appears in FDA public data with 9 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0478-2022, Class II) was initiated on November 3, 2021. Its most recent 510(k) clearance was granted on June 7, 2005.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0478-2022 | Class II | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 | November 3, 2021 |
| Z-0477-2022 | Class II | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | November 3, 2021 |
| Z-1560-2021 | Class II | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. | April 15, 2021 |
| Z-0697-2021 | Class II | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combin | November 20, 2020 |
| Z-2482-2019 | Class II | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical | July 31, 2019 |
| Z-2484-2019 | Class II | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surg | July 31, 2019 |
| Z-2483-2019 | Class II | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical | July 31, 2019 |
| Z-1500-2017 | Class II | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). | January 5, 2017 |
| Z-2411-2012 | Class II | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine | August 17, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | June 7, 2005 |