HomeUSAMedical Device Technologies, Inc.

Medical Device Technologies, Inc.

USA · Gainesville
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
46510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 46 510(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
10active device licences
Class I 1Class II 8Class III 1
12 including historic records
TWTaiwanTFDA
0valid device licences
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, 46 510(k), 0 PMA, 234 excluded
Brazil2 confirmed, 100 excluded
Saudi Arabia0 confirmed, 40 excluded
Canada10 confirmed, 20 excluded
Manufacturer names merged into this page: MEDICAL DEVICE TECHNOLOGIES, INC. · Medical Device Technologies,Inc.

Company information

Country
USA
City
Gainesville

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

21992
11994
11995
31996
11997
221998
31999
32000
12001
12002
12003
22004
32005
12006
12010

Registration details (sample)

MarketIdentifierNameClass / date
USK101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT2010-08-27
USK053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR2006-01-26
USK051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR2005-08-30
BR10349000744KIT KYPHOPAK KPT1005 - CDSClass II
BR10349000746KIT KYPHOPAK KPT1001Class II
CA5717RE-USABLE BIOPSY INSTRUMENTSClass I
CA5719ULTRA-VAC ADJUSTABLE AUTOMATED ASPIRATION BIOPSY SYSTEMClass II
CA5720ULTRA-CUT ADJUSTABLE AUTOMATED BIOPSY SYSTEMClass II

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