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Entellus Medical, Inc.

USA · Plymouth
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia, Hong Kong, Israel — 6 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
13listed device types
Class I 8Class II 5Class III 0
plus 13 registration records and 28 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
15active ARTG entries
Class I 5Class III 2IIa 7Class Is (sterile) 1
HKHong KongMDACS
2valid listings
Class II 1Class IV 1
ILIsraelAMAR
2registrations
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 States13 registration records, 28 510(k), 0 PMA
Saudi Arabia3 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: Entellus Medical, Inc · ENTELLUS MEDICAL, INC. · Entellus Medical, Inc.
Same-named companies — This database also contains companies with near-identical names: Entellus Medical, Inc. (Aka Stryker Ent). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Plymouth

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

32008
12009
22010
62011
52012
32013
22014
22015
22017
12019
12022

FDA listed device types

showing 8 of 13
Instrument, Ent Manual Surgical 1Splint, Intranasal Septal 1Forceps, Ent 1Knife, Ent 1Balloon, Epistaxis 1Camera, Cine, Endoscopic, Without Audio 1Tray, Surgical, Ent 1Field Generator Positioning Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220027Audion ET dilation system2022-04-12
USK192661LATERA Absorbable Nasal Implant System2019-11-10
USK163509XprESS ENT Dilation System2017-04-05
SAME0000022003SFDAA00003MiniFESS Maxillary Seeker Set—
SAME0000022003SFDAA00001MiniFESS Sphenoid Seeker/Freer—
CA88731PATHASSIST LIGHT FIBERClass II
CA88732XPRESS PRO ENT DILATION SYSTEMClass II
CA89351FINESS ENDOSCOPEClass II

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