Acufex Microsurgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 79
What Acufex Microsurgical, Inc. makes
Acufex Microsurgical, Inc. manufactures arthroscopic surgical instruments and orthopaedic fixation devices, including metal and absorbable interference screws, ACL cannulas and sheaths, arthroscopic shavers, shoulder guide systems, and fluoroscopy protection gloves. Their portfolio also covers hand-held tools like graspers, dissectors, forceps, and needle holders, as well as fixation devices such as polyglyconate absorbable tacks and delivery systems for ACL reconstruction.
The company’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) database, reflecting their authorised status under US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 79 devicesShowing 1-50 of 79
Frequently asked questions
How many devices does Acufex Microsurgical, Inc. have in the registry?
The registry currently lists 79 devices for Acufex Microsurgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acufex Microsurgical, Inc.'s devices?
Among its 50 most recently registered devices, Acufex Microsurgical, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Acufex Microsurgical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Acufex Microsurgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acufex Microsurgical, Inc. in the registry?
The most recently registered devices listed for Acufex Microsurgical, Inc. include ACUFEX METAL ACL CANNULA, ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW, ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM and ACUFEX ARTHROSCOPIC SHAVER.