FDA.reportPublic FDA data

SONAVEX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146807353014680735SONAVEX, INC.1N2026-01-012835 ODONNELL ST STE 200 Baltimore MD US 21224

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B53620001EchoMark LP - EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.(443)862-2024contact@sonavex.com
B53630001EchoMark - EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.(443)862-2024contact@sonavex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2196591726766907K243479EchoGuide (Version 1)IYO2025-04-23
2196591983813496K190039EchoSure Diagnostic Ultrasound SystemIYO2019-03-08
2196591515403970K180621EchoMark, EchoMark LPNEU2018-06-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO22025-04-23
NEU12018-06-06

PMN#

GUDID#