HomeUSANew World Medical, Inc.

New World Medical, Inc.

USA · Rancho Cucamonga
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 2Class II 3Class III 0
plus 6 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
4 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
2valid listings
Class II 1Class III 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 1Class 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 States6 registration records, 12 510(k), 0 PMA, 58 excluded
Brazil1 confirmed, 20 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada1 confirmed, 10 excluded
Manufacturer names merged into this page: New World Medical, Inc. · NEW WORLD MEDICAL INC. · NEW WORLD MEDICAL, INC

Company information

Country
USA
City
Rancho Cucamonga

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

11993
11998
11999
12006
12016
12017
12019
12021
22023
12024
12025

FDA listed device types

Pump, Infusion, Ophthalmic 1Knife, Intraocular Pressure Lowering 1Implant, Eye Valve 1Trabeculotome 1Cannula, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243503VIA360™ Surgical System2025-02-14
USK220891Kahook Dual Blade Glide (KDB Glide)2024-05-17
USK231051Ahmed® Glaucoma Valve Model FP82023-05-12
BR80170280058Kahook Dual Blade - bisturi manual oftálmicoClass II
CA96473KAHOOK DUAL BLADEClass II

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