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Radiation Products, LLC

USA · Atlantis

✓ 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

22listed device types

Class I 20Class II 2Class III 0

plus 23 registration records and 14 510(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 States23 registration records, 14 510(k), 0 PMA, 33 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: RADIATION PRODUCTS DESIGN, INC. · SURGICAL RADIATION PRODUCTS LLC

FDA 510(k) clearances by year

11979

61980

11983

11985

11998

12002

12004

12015

12018

FDA listed device types

showing 8 of 22

Lift, Patient, Non-Ac-Powered 1Protractor 1Device, Transfer, Patient, Manual 1Stains, Dye Solution 1Bed, Manual 1Stand, Infusion 1Caliper 1Shield, Eye, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180027	ACCUSYTE 3D Fiducial Marker	2018-07-18
US	K150382	Radio Therapy Treatment Chair	2015-09-16
US	K040804	.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR	2004-04-28

Radiation Products, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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