Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Bioventus medical devices: approvals, recalls and adverse events

Stock: BVS. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

59 supplements

Recalled products

0 class I

Adverse event reports

197

10 deaths reported

How many recalls does Bioventus have?

Bioventus has 2 recalled medical device products in 2 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Dec 17, 2020. In 2019 it had 1 recalled products.

How many medical devices has Bioventus had cleared or approved?

8 510(k) clearances, 0 De Novo grants and 2 original PMA approvals for high-risk devices, plus 59 PMA supplements (changes to approved devices). The newest decision was on Aug 26, 2026.

How many adverse event reports name Bioventus devices?

197 reports in total: 10 deaths, 150 injuries and 32 malfunctions were reported. 30 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	1	0	0	1
2025	2	0	0	1
2024	1	0	0	0
2023

Newest clearances and approvals

StimTrial Neuromodulation System
K253877 · 510(k) clearance · Aug 26, 2026
StimTrial Neuromodulation System
K243782 · 510(k) clearance · Jul 16, 2025
TalisMann Neuromodulation System
K243678 · 510(k) clearance · Jul 3, 2025
Allograft Delivery Device (OFAC-C)
K233368 · 510(k) clearance · Jun 25, 2024
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
K233490 · 510(k) clearance · Dec 5, 2023
neXus Ultrasonic Surgical Aspirator System
K231117 · 510(k) clearance · Jun 23, 2023
SIGNAFUSE Bioactive Bone Graft
K193513 · 510(k) clearance · Jun 18, 2020
DUROLANE
P170007 · PMA approval · Aug 29, 2017
MCS Bone Graft
K162860 · 510(k) clearance · Feb 13, 2017
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
P900009 · PMA approval · Oct 5, 1994

Newest recalls

Devices with the most adverse event reports

By product code, all years

Acid, Hyaluronic, Intraarticular (MOZ, class 3)146
Stimulator, Bone Growth, Non-Invasive (LOF, class 2)31
Stimulator, Peripheral Nerve, Implanted (Pain Relief) (GZF, class 2)9
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep (LPQ, class 2)4
Filler, Bone Void, Calcium Compound (MQV, class 2)2
Instrument, Ultrasonic Surgical (LFL, class U)2
Stimulator, Invasive Bone Growth (LOE, class 3)1
Stimulator, Muscle, Powered (IPF, class 2)1
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (IMG, class 2)1

All device makers and procedures · BVS stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to BVS with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	0	13	2
2025	0	30	1
2024	0	35	2
2023	0	22	1
2022	0	14	1
2021	0	26	2
2020	1	11	-
2019	1	23	1
2018	0	7	-
2017	0	1	-
2016	0	5	-
2015	0	5	-
2014	0	2	-
2013	0	3	-