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Home›USA›ZAVATION MEDICAL PRODUCTS, LLC.

ZAVATION MEDICAL PRODUCTS, LLC.

USA · Flowood
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
31510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 31 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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 States0 registration records, 31 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: ZAVATION MEDICAL PRODUCTS, LLC.

Company information

Country
USA
City
Flowood

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

72018
52019
42020
42021
42022
42023
12024
12025
12026

Registration details (sample)

MarketIdentifierNameClass / date
USK253943Tiger 2 System2026-07-24
USK243908Tiger 2 System2025-02-03
USK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System2024-04-10
BR10355870330Kit Cânula InterV Direct SingleClass II
BR10355870328Kit Cânula InterV Direct DoubleClass II

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