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Home›USA›Procept Biorobotics, Corporation

Procept Biorobotics, Corporation

USA · San Jose
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Israel — 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
5listed device types
Class I 0Class II 5Class III 0
plus 14 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIa 2IIb 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
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 States14 registration records, 9 510(k), 0 PMA
Manufacturer names merged into this page: PROCEPT BioRobotics Corporation · Procept Biorobotics c/o HealthLink Europe B.V. · PROCEPT BIOROBOTICS CORPORATION
Same-named companies — This database also contains companies with near-identical names: Procept Biorobotics c/o HealthLink Europe B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Jose

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
PROCEPT BioRobotics Corp
CIK
0001588978
Registration status
Active
Listing status
Listed (PRCT)

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
22021 · K212835
12023 · K231024
22024 · K241952
12025 · K251082
22026 · K260723

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Fluid Jet Removal System 1System, Imaging, Pulsed Doppler, Ultrasonic 1Drape, Urological, Disposable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)2026-07-09
USK253211AQUABEAM Robotic System2026-06-23
USK251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)2025-10-10

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