Company ยท CH
Haag-Streit USA Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2014. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 4 |
| EPT | Microscope, Surgical | 3 |
| HJB | Instrument, Measuring, Corneal Radius | 2 |
| NFJ | System, Image Management, Ophthalmic | 2 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 1 |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 |
| OBO | Tomography, Optical Coherence | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2014 | K142423 | EyeSuite Imaging Haag-Streit AG, CH | NFJ |
| Mar 19, 2010 | K100202 | SLIT LAMP BO 900, BQ 900, BP900 Haag-Streit AG, CH | HJO |
| Oct 20, 2009 | K082891 | LENSTAR, MODEL LS900 Haag-Streit AG | HJO |
| Jun 7, 2005 | K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY Haag-Streit USA, Inc. | HJK |
| Aug 14, 1998 | K982057 | BC 900 SLIT LAMP Haag-Streit AG, CH | HJO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 Open, Classified |
OBO | K142953 |
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Open, Classified |
HLI | K142953 |
| Apr 15, 2021 | Haag-Streit USA Inc Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. Open, Classified |
HJO | K082891 |
| Nov 20, 2020 | Haag-Streit USA Inc Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. Open, Classified |
HRM | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900A NIR
Reference # 657 822
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment Terminated |
EPT | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900A
Reference # 657 821
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and Terminated |
EPT | None listed |
| Jul 31, 2019 | Haag-Streit USA Inc HS Hi-R NEO 900
Reference # 657 820
Serial # from 101
Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and Terminated |
EPT | None listed |
| Jan 5, 2017 | Haag-Streit USA Inc EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). Terminated |
NFJ | K142423 |
| Sep 20, 2012 | Haag-Streit USA Inc Octopus 101 Perimeter; PeriTrend Software Analysis
A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of Terminated |
HPT | None listed |
| Jan 11, 2012 | Haag-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 |
HJB | None listed |
| Aug 9, 2011 | Haag-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 |
HJB | K082891 |
| Jun 24, 2010 | Haag-Streit USA Inc Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland.
Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate pow Terminated |
HLF | K082891 |