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Bioventus, LLC

USA · Durham

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Hong Kong, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

14listed device types

Class I 1Class II 11Class III 1unclassified 1

plus 41 registration records and 6 510(k), 61 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 4Class III 1IIa 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States41 registration records, 6 510(k), 61 PMA, 1 excluded

Manufacturer names merged into this page: Bioventus LLC · BIOVENTUS LLC

Business registration

Legal name: Bioventus Inc.
CIK: 0001665988
Registration status: Active
Listing status: Listed (BVS)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12017 · K162860

12020 · K193513

12023 · K233490

12024 · K233368

22025 · K243782

FDA listed device types

showing 8 of 14

Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Neuromuscular, External Functional 1Stimulator, Muscle, Powered 1Computerized Cognitive Assessment Aid, Exempt 1Filler, Bone Void, Calcium Compound 1Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep 1System, Isokinetic Testing And Evaluation 1Stimulator, Peripheral Nerve, Implanted (Pain Relief) 1

Market	Identifier	Name	Class / date
US	K243782	StimTrial Neuromodulation System	2025-07-16
US	K243678	TalisMann Neuromodulation System	2025-07-03
US	K233368	Allograft Delivery Device (OFAC-C)	2024-06-25

Bioventus, LLC

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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