FDA.reportPublic FDA data

SYNAPSE BIOMEDICAL INC.

Matched from indexed company URL: Synapse Biomedical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058683923005868392SYNAPSE BIOMEDICAL INC.1N2026-01-01300 Artino Street Oberlin OH US 44074

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
00852184003007NeuRx Diaphragm Pacing System - 20-00351-888-767-3770customerservice@synapsebiomedical.com
00852184003038NeuRx DPS™ Surgical Kit, HDE - 20-00281-888-767-3770customerservice@synapsebiomedical.com
00852184003045NeuRx DPS Patient Kit - 20-00361-888-767-3770customerservice@synapsebiomedical.com
00852184003090STERILE Mapping Probe - 21-0001-991-888-767-3770customerservice@synapsebiomedical.com
00852184003106STERILE Indifferent Electrode - 21-0004-991-888-767-3770customerservice@synapsebiomedical.com
00852184003113STERILE Lead Tunnelers - 21-0007-991-888-767-3770customerservice@synapsebiomedical.com
00852184003120STERILE Blue Cable Set - 21-0009-991-888-767-3770customerservice@synapsebiomedical.com
008521840036182 Pack, Electrode Delivery Tool Kit - 20-00741-888-767-3770customerservice@synapsebiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
851521765387596P200018NeuRX Diaphragm Pacing System (DPS)OIR2023-03-31
851521728051032K242704Synchrony (20-3000)GZI2025-06-05
851521548301151H100006
851521120169820H070003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZI12025-06-05

GUDID#

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