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Home›USA›APEX MEDICAL SOLUTIONS LLC

APEX MEDICAL SOLUTIONS LLC

USA · Knoxville
✓ 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
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 36 510(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 States2 registration records, 36 510(k), 0 PMA, 24 excluded
Brazil0 confirmed, 6 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: APEX MEDICAL SOLUTIONS LLC · APEX MEDICAL, INC.

Company information

Country
USA
City
Knoxville

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

11991
11994
11997
31998
12000
52001
32002
22004
12005
12006
22007
12009
22011
22012
12013
12014
12015
12019
12020
12022

FDA listed device types

Instrument, Microsurgical 1Support, Patient Position 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213577VenAir, Sequential Compression System2022-06-28
USK193206WiZARD 510 Nasal Mask2020-10-29
USK182394WiZARD 310/320 Series CPAP Mask2019-05-17

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