HomeUSAMEGADYNE MEDICAL PRODUCTS, INC.

MEGADYNE MEDICAL PRODUCTS, INC.

USA · Cincinnati
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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
5listed device types
Class I 1Class II 4Class III 0
plus 27 registration records and 50 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
18 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
4device registrations
CLASS B 1CLASS C 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
20active ARTG entries
Class I 8IIa 2IIb 8Class Is (sterile) 2
HKHong KongMDACS
3valid listings
Class II 1Class III 2
ILIsraelAMAR
10registrations
RURussiaRoszdravnadzor
4active registrations
Class 2b 4
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 States27 registration records, 50 510(k), 0 PMA
Manufacturer names merged into this page: MEGADYNE MEDICAL PRODUCTS, INC. · MEGADYNE MEDICAL PRODUCTS INC · MEGADYNE MEDICAL PRODUCTS, INC

Company information

Country
USA
City
Cincinnati

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

21990
171991
11992
31993
51994
31995
31997
11998
12002
12003
12004
22005
12007
22008
12014
12015
12019
22020
12022
12024

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Exhaust, Surgical 1Electrode, Electrosurgical 1Electrocautery, Gynecologic (And Accessories) 1Tube, Smoke Removal, Endoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)2024-07-12
USK213696ETHICON Megadyne Electrosurgical Generator2022-01-21
USK200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor2020-06-26

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