HomeUSAApplied Medical Distribution Center

Applied Medical Distribution Center

USA · Irvine
✓ 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
323listed device types
Class I 118Class II 151Class III 47unclassified 7
plus 857 registration records and 1 510(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 States857 registration records, 1 510(k), 0 PMA, 46 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: Bard European Distribution Center NV · Olive Branch Distribution Center · Medtronic Distribution Center · NOBEL BIOCARE DISTRIBUTION CENTER BV
Same-named companies — This database also contains companies with near-identical names: Best Manufacturing Company-Distribution Center, Medtronic Distribution Center. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Irvine

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

12003 · K030075

FDA listed device types

showing 8 of 323
Electrosurgical, Cutting & Coagulation & Accessories 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Endoscopic Access Overtube, Gastroenterology-Urology 1Cerclage, Fixation 1Dental Stereotaxic Instrument 1Implant, Endosseous, Root-Form 1

Registration details (sample)

MarketIdentifierNameClass / date
USK030075NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)2003-03-05

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