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Home›USA›INTUIT MEDICAL PRODUCTS, LLC

INTUIT MEDICAL PRODUCTS, LLC

USA · Lawrenceville
✓ 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
4listed device types
Class I 3Class II 1Class III 0
plus 5 registration records and 4 510(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 States5 registration records, 4 510(k), 0 PMA
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: INTUIT MEDICAL PRODUCTS, LLC
Same-named companies — This database also contains companies with near-identical names: Intuit Medical, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Lawrenceville

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

12013 · K123264
12015 · K143738
12016 · K153484
12020 · K181546

FDA listed device types

Instrument, Ent Manual Surgical 1Forceps, Ent 1Spatula, Surgical, General & Plastic Surgery 1Bronchoscope Accessory 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181546Dillard Nasal Balloon Catheter2020-01-03
USK153484Dillard Airway Dilatation System2016-07-27
USK143738DSS Sinusplasty Balloon Catheter2015-08-27

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