Blade Works, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Blade Works, Inc. makes
Blade Works, Inc. manufactures single-use microkeratome blades, including the Model 7061, designed for precision corneal surgery, as well as disposable Alk tubing for ophthalmic procedures. These products are intended for use in refractive surgeries and related eye procedures requiring sterile, disposable cutting tools and tubing components.
The company’s portfolio is classified under FDA’s Class I medical devices, with individual products authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Bladeworks Microkeratome Blade, Model 7061 Ref K020079
Regimes: 510(k) Registry: 510(k)Bladeworks Microkeratome Blade Ref K993225
Regimes: 510(k) Registry: 510(k)Bladeworks Disposable Alk Tubing Ref K993591
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Blade Works, Inc. have in the registry?
The registry currently lists 3 devices for Blade Works, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blade Works, Inc.'s devices?
Among its 3 most recently registered devices, Blade Works, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Blade Works, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Blade Works, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Blade Works, Inc. in the registry?
The most recently registered devices listed for Blade Works, Inc. include BLADEWORKS MICROKERATOME BLADE, MODEL 7061, BLADEWORKS MICROKERATOME BLADE and BLADEWORKS DISPOSABLE ALK TUBING.