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AXIAL MEDICAL

USA · Ivyland
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
33listed device types
Class I 1Class II 31Class III 0unclassified 1
plus 118 registration records and 5 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States118 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: AXIAL MEDICAL · AXIAL MEDICAL PRINTING LIMITED
Same-named companies — This database also contains companies with near-identical names: AXIAL MEDICAL PRINTING LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Ivyland

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.

FDA 510(k) clearances by year

12022 · K221511
22023 · K232841
12024 · K231607
12025 · K250369

FDA listed device types

showing 8 of 33
Posterior Cervical Screw System 1Detector And Alarm, Arrhythmia 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Posterior Metal/Polymer Spinal System, Fusion 1Intervertebral Fusion Device With Bone Graft, Lumbar 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250369Axial3D Insight2025-09-18
USK231607Axial3D Cloud Segmentation Service2024-01-24
USK232841Axial3D Insight2023-11-15

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