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Misonix, LLC

Last updated September 17, 2026

About

Bioventus products, orthobiologics, biologics and devices for bone healing and osteoartritis pain relief are known as innovations for active healing.

From the manufacturer's own website. Source

Information

Country: US
Address: 1938 New Hwy, Farmingdale, NY, 11735
Website: www.bioventus.com
LinkedIn: linkedin.com/company/bioventus
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2435119
DUNS Number: —

Catalogue (204)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
SonaStar	MXA-TRAY	FDA UDI	Class II	Active
neXus	100-24-0002	FDA UDI	U	Active
SonaStar	SYSTEM-M300-2	FDA UDI	Class II	Active
SonicOne O.R.	E-SOGEN-OR	FDA UDI	U	Active
SonaStar	MXA-D212+	FDA UDI	Class II	Active
neXus	130-35-5502	FDA UDI	U	Active
BoneScalpel	MXB-20LC	FDA UDI	U	Active
SonaStar	CFSX3-M200-3	FDA UDI	Class II	Active
BoneScalpel	MXB-10LS	FDA UDI	U	Active
SonaStar	E0702ABC07	FDA UDI	Class II	Active
SonaStar	SYSTEM-M200-0	FDA UDI	U	Active
neXus	100-62-0000	FDA UDI	U	Active
BoneScalpel	BCM-T	FDA UDI	U	Active
BoneScalpel	MXB-MIS-20LCRS	FDA UDI	U	Active
SonaStar	SYSTEM-M300-3	FDA UDI	Class II	Active
SonaStar	CFSM6-H152	FDA UDI	Class II	Active
BoneScalpel	MXB-25	FDA UDI	U	Active
neXus	130-33-2411	FDA UDI	U	Active
SonicOne Clinic	E-SOP-F1	FDA UDI	U	Active
SonaStar	SYSTEM-M300-0	FDA UDI	Class II	Active
SonaStar	MXA-S002	FDA UDI	U	Active
SonaStar	SYSTEM-M380-3	FDA UDI	Class II	Active
SonaStar	SYSTEM-M280-0 (rev Jx)	FDA UDI	Class II	Active
SonaStar	CFSX3-M200-2	FDA UDI	Class II	Active
SonaStar	MXA-D224	FDA UDI	Class II	Active
SonaStar	CFSM6-C141	FDA UDI	Class II	Active
SonaStar	CFSX3-M200	FDA UDI	Class II	Active
SonaStar	CFSX3-M200-0	FDA UDI	Class II	Active
SonicOne (O.R. & Clinic)	E-CWRCH	FDA UDI	U	Active
BoneScalpel	MXB-MIS-10	FDA UDI	U	Active
SonaStar	MXA-D212	FDA UDI	Class II	Active
SonaStar	CFSM4-M100	FDA UDI	Class II	Active
SonaStar	CFSM6-H190	FDA UDI	Class II	Active
SonaStar	MXA-HF	FDA UDI	Class II	Active
SonaStar	SYSTEM-M200-2 (rev Ax)	FDA UDI	Class II	Active
BoneScalpel	BCM-SS	FDA UDI	U	Active
SonaStar	SYSTEM-M360-1	FDA UDI	Class II	Active
Sonicone Plus Ultrasound Wound Care System And Accessories	K123980	FDA 510(k)	Class II	Active
Ultrasonic Surgical Aspirator System, Model Fs 1000 Rf	K062471	FDA 510(k)	U	Active
Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System	K070313	FDA 510(k)	U	Active
Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System	K042096	FDA 510(k)	Class II	Active
Alliger Ultrasonic Surgical System Model Auss-4	K000927	FDA 510(k)	U	Active
Misonix Inc. Fs 1000 Rf Ultrasonic Surgical Aspirator System	K032690	FDA 510(k)	U	Active
Alliger Ultrasonic Surgical System Model Auss-5	K012028	FDA 510(k)	U	Active
neXus Ultrasonic Surgical Aspirator System	K190160	FDA 510(k)	U	Active
Misonix Sonicone(r) Ultrasonic Wound Care System And Accessories	K112782	FDA 510(k)	Class II	Active
Sonatherm 600i Ultrasonic Lesion Generating System	K070779	FDA 510(k)	Class II	Active
Misonix Irrigation System Moedl Bc20p	K013417	FDA 510(k)	Class I	Active
neXus Ultrasonic Surgical Aspirator System	K221235	FDA 510(k)	U	Active
neXus Ultrasonic Surgical Aspirator System	K212060	FDA 510(k)	U	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 13, 2003	Z-0070-04	—	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.