7 results
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Sources: EU EUDAMED, US FDA
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 accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·September 11, 2019
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 accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·September 11, 2019
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 and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·September 11, 2019
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Enforcement
Class II
·Terminated·Bien Air Dental SA·September 30, 2015
JK Bariatric Beds, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014