Paradigm Medical Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Paradigm Medical Industries, Inc. makes
Paradigm Medical Industries, Inc. manufactures automated systems for ophthalmic surgery, including modular workstations and ultrasonic biomicroscopes for intraocular procedures. Their portfolio includes chamber maintenance modules for cataract surgery, blood flow analyzers for ocular diagnostics, and precision surgical tools like the Quitetip and Phacopak. The company also produces modular photon-based systems for surgical applications and high-resolution imaging devices, such as the Ultrasonic Bio-Microscope.
The company’s devices are classified under Class II regulatory categories and are listed in the FDA’s 510(k) Premarket Notification Database. These products are subject to U.S. FDA oversight under the Federal Food, Drug, and Cosmetic Act. The manufacturer is based in the United States.
Catalogue
Automated Chamber Maintenance Module Ref K971795
Regimes: 510(k) Registry: 510(k)Ubm Plus, Model P45 Ref K003141
Regimes: 510(k) Registry: 510(k)Blood Flow Analyzer Ref K970887
Regimes: 510(k) Registry: 510(k)Phacopak Ref K974719
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Quitetip Ref K981109
Regimes: 510(k) Registry: 510(k)Blood Flow Analyzer (Bfa), Model 408-100-01 Ref K023245
Regimes: 510(k) Registry: 510(k)Precisionist Thirty Thousand Ref K953447
Regimes: 510(k) Registry: 510(k)Ultrasonic Bio-Microscope, Model P60 Ref K050980
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Paradigm Medical Industries, Inc. have in the registry?
The registry currently lists 10 devices for Paradigm Medical Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Paradigm Medical Industries, Inc.'s devices?
Among its 10 most recently registered devices, Paradigm Medical Industries, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Paradigm Medical Industries, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Paradigm Medical Industries, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Paradigm Medical Industries, Inc. in the registry?
The most recently registered devices listed for Paradigm Medical Industries, Inc. include AUTOMATED CHAMBER MAINTENANCE MODULE, UBM PLUS, MODEL P45, BLOOD FLOW ANALYZER and PHACOPAK.