Misonix, LLC
United StatesFDA applicant, unverified FDA FEI 2435119
Misonix, LLC is a medical device manufacturer, with 205 devices listed in FDA GUDID and FDA 510(k) (FDA Unclassified, Class II and Class I) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 205
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 187
- FDA 510(k) 18
- Device classes
- FDA Unclassified 126
- FDA Class II 78
- FDA Class I 1
- FDA recalls
- Identifiers
- FDA FEI 2435119
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Misonix, LLC makes
Misonix, LLC manufactures reusable and single-use components for ultrasonic surgical systems, including handpiece tips for soft-tissue and hard-tissue procedures, reusable handpieces, cooling sleeves, foot-switches, irrigation tubing sets, and surgical torque wrenches. Their product line also includes ultrasonic surgical generators and foot-switches designed for use in operating rooms and clinical settings.
The company’s devices are classified under FDA’s Class II and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 205 devicesShowing 1-50 of 205
Company details
- FDA FEI number
- 2435119
- Address
- 1938 New Hwy, Farmingdale, NY, 11735
- Website
- www.bioventus.com
- linkedin.com/company/bioventus
FDA recalls
FDA recall records list 1 recall initiated by Misonix, LLC, initiated on 2003-08-13. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 13 Aug 2003 Z-0070-04 Unclassified (pre-2012) Terminated Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
Full distribution text
- 13 Aug 2003 Z-0070-04 Unclassified (pre-2012) Terminated Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
From the company website
Bioventus products, orthobiologics, biologics and devices for bone healing and osteoartritis pain relief are known as innovations for active healing.
Frequently asked questions
How many devices does Misonix, LLC have in the registry?
The registry currently lists 205 devices for Misonix, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Misonix, LLC's devices?
Among its 50 most recently registered devices, Misonix, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Misonix, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Misonix, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Misonix, LLC?
FDA recall records list 1 recall initiated by Misonix, LLC, the most recent initiated on 13 Aug 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Misonix, LLC in the registry?
The most recently registered devices listed for Misonix, LLC include neXus Ultrasonic Surgical Aspirator System, neXus 120-31-13C3, SonaStar SYSTEM-M280-1 (rev Jx) and BoneScalpel BCM-HP KIT.