American Safety Equipment Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What American Safety Equipment Corp. makes
American Safety Equipment Corp. manufactures surgical instruments for orthopedic and trauma procedures, including wire drivers, oscillating and reciprocating saws, micro drills, chisels, and Kirschner wires. Their product line also includes specialized tools like the Cara-Stain Model 3000, designed for precise surgical applications.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These instruments are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Surgical Wire Driver Ref K760960
Regimes: 510(k) Registry: 510(k)Surgical Oscillating Saw Ref K760958
Regimes: 510(k) Registry: 510(k)Cara-Stain Model 3000 Ref K771699
Regimes: 510(k) Registry: 510(k)Kirschner Wire Ref K801010
Regimes: 510(k) Registry: 510(k)Surgical Chisel Ref K760959
Regimes: 510(k) Registry: 510(k)Surgical Reciprocating Saw Ref K760957
Regimes: 510(k) Registry: 510(k)Surgical Micro Drill Ref K760956
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Safety Equipment Corp. have in the registry?
The registry currently lists 7 devices for American Safety Equipment Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Safety Equipment Corp.'s devices?
Among its 7 most recently registered devices, American Safety Equipment Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do American Safety Equipment Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for American Safety Equipment Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Safety Equipment Corp. in the registry?
The most recently registered devices listed for American Safety Equipment Corp. include SURGICAL WIRE DRIVER, SURGICAL OSCILLATING SAW, CARA-STAIN MODEL 3000 and KIRSCHNER WIRE.