HomeUSASynapse Biomedical, Inc.

Synapse Biomedical, Inc.

USA · Oberlin
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 7 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
4listed device types
Class I 1Class II 2Class III 1
plus 4 registration records and 1 510(k), 1 PMA
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
5 including historic records
TWTaiwanTFDA
2valid device licences
Class III 2
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
10active ARTG entries
Class I 1IIa 4IIb 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States4 registration records, 1 510(k), 1 PMA, 5 excluded
Manufacturer names merged into this page: SYNAPSE BIOMEDICAL INC. · SYNAPSE BIOMEDICAL,INC.

Company information

Country
USA
City
Oberlin

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

12025 · K242704

FDA listed device types

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator 1Goniometer, Ac-Powered 1Stimulator, Neuromuscular, External Functional 1Stimulator, Muscle, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242704Synchrony (20-3000)2025-06-05

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