HomeUSAUnited States Import Sales

United States Import Sales

USA · Memphis
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
51listed device types
Class I 11Class II 40Class III 0
plus 96 registration records and 326 510(k), 5 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
29registered devices
Class I 3Class II 26
32 including historic records
SASaudi ArabiaSFDA
26registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
65active device licences
Class II 44Class III 16Class IV 5
110 including historic records
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 States96 registration records, 326 510(k), 5 PMA, 1 excluded
Brazil29 confirmed, 0 excluded
Saudi Arabia26 confirmed, 0 excluded
Canada65 confirmed, 0 excluded
Manufacturer names merged into this page: UNITED STATES ENDOSCOPY GROUP, INC. · UNITED STATES ENDOSCOPY GROUP INC., ALSO TRADING AS US ENDOSCOPY · UNITED STATES SURGICAL, A DIV. OF TYCO HEALTHCARE GROUP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP, LP · UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP · UNITED STATES ENDOSCOPY GROUP, INC
Same-named companies — This database also contains companies with near-identical names: United States Dental, United States Dental Laser, Inc., UNITED STATES ENDOSCOPY GROUP, INC., UNITED STATES ENDOSCOPY GROUP INC., ALSO TRADING AS US ENDOSCOPY. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Memphis

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

52000
62001
32002
32003
52004
22005
52006
32007
32008
62009
42010
42011
52012
22013
52014
52015
32017
42018
22019
22020

FDA listed device types

showing 8 of 51
Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Container, Specimen, Sterile 1Endoscopic Bite Block 1Surgical Table Cushion 1Tray, Biopsy, Without Biopsy Instruments 1Snare, Non-Electrical 1Table And Attachments, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
USK192265gi-4000 Electrosurgical Generator2020-05-21
USK200745Lariat, Hot/Cold Snare2020-04-21
USK192059Bio Guard Air/Water & Suction Valves2019-09-17
BR10349000075VISIPORT - TROCARTE OPTICO DESCARTAVEL COM CANULAAUTO SUTUREClass II
BR10349000004VERSAPORT CÂNULA E TROCARTE DESCARTÁVEL AUTO SUTUREClass II
BR10349000117ENDO CLOSE DISPOSITIVO DE SUTURA DESCARTAVEL AUTOSUTUREClass II
SAME0000003748SFDAA00027MIO MEDICAL DEVICE ORGANIZER
SAME0000003748SFDAA00028CLEANING BRUSH
CA64824DISPOSABLE NAKAO SNAREClass II
CA64820DISPOSABLE HOT BIOPSY FORCEPSClass II
CA64822REUSABLE BIOPSY FORCEPSClass II

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