Synapse Biomedical Inc

FDA Filings

This page includes the latest FDA filings for Synapse Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005868392
FEI Number3005868392
NameSYNAPSE BIOMEDICAL INC.
Owner & OperatorSynapse Biomedical Inc.
Contact Address300 Artino Street
Oberlin OH 44074 US
Official Correspondent
  • Mark Barbutes
  • x-440-7742488-114
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address300 Artino Street
Oberlin, OH 44074 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Synapse Biomedical, Inc.
2 Pack, Electrode Delivery Tool Kit 2021-03-24
Synapse Biomedical, Inc.
Disposable Electrode Delivery Tool 2021-03-24
Synapse Biomedical, Inc.
NeuRx DPS™ Pacing System, European CE Patient Kit 2018-03-29
Synapse Biomedical, Inc.
External Pulse Generator 2018-03-29
Synapse Biomedical, Inc.
Socket Pusher 2018-03-29
Synapse Biomedical, Inc.
Clinical Station 2018-03-29
Synapse Biomedical, Inc.
Active Sensor Module 2018-03-29
Synapse Biomedical, Inc.
Electrode Delivery Tool Kit, MedCoat, HDE 2018-03-29
Synapse Biomedical, Inc.
Surface Electrode, 4-pack with Interconnect 2018-03-29
Synapse Biomedical, Inc.
Surface Electrode, Single-Pack 2018-03-29
Synapse Biomedical, Inc.
Clinician Connector Repair Parts Kit 2018-03-29
Synapse Biomedical, Inc.
Clinician Connector Kit 2018-03-29
Synapse Biomedical, Inc.
Surgical Connector Kit 2018-03-29
Synapse Biomedical, Inc.
Clinician Crimp Tool 2018-03-29
Synapse Biomedical, Inc.
Airline Travel Battery Pack 2018-03-29
Synapse Biomedical, Inc.
Extended-Life Battery - 3 Pack 2018-03-29
Synapse Biomedical, Inc.
Electrode Delivery Tool Kit MedCoat, CE 2018-03-29
Synapse Biomedical, Inc.
Patient Cable 2018-03-29
Synapse Biomedical, Inc.
Silicone Adhesive Kit 2018-03-29
Synapse Biomedical, Inc.
Connector Holder Kit 2018-03-29
Synapse Biomedical, Inc.
Clinical Station Kit, ALS HDE 2018-03-29
Synapse Biomedical, Inc.
Surgical Site Start-up Kit, ALS HDE 2018-03-29
Synapse Biomedical, Inc.
System Destination Kit, 2-EPG, Canada 2018-03-29
Synapse Biomedical, Inc.
System Destination Kit, ALS HDE, US 2018-03-29
Synapse Biomedical, Inc.
System Destination Kit, SCI HDE, US 2018-03-29
Synapse Biomedical, Inc.
System Kit, ALS HDE 2018-03-29
Synapse Biomedical, Inc.
Anode Replacement Parts Kit 2018-03-29
Synapse Biomedical, Inc.
Spare Surgical Kit 2018-03-29
Synapse Biomedical, Inc.
Clinical Station Kit 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ System Kit, Canada 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Pacing System, European CE Patient Kit 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Surgical Kit 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ External Pulse Generator 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Clinical Station Kit, HDE 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE 2018-03-29
Synapse Biomedical, Inc.
STERILE Touchproof Cable, White 2018-03-29
Synapse Biomedical, Inc.
STERILE Touchproof Cable Yellow 2018-03-29
Synapse Biomedical, Inc.
STERILE Touchproof Cable, Orange 2018-03-29
Synapse Biomedical, Inc.
STERILE Touchproof Cable, Green 2018-03-29
Synapse Biomedical, Inc.
STERILE PermaLoc Electrode, 60cm 2018-03-29
Synapse Biomedical, Inc.
STERILE Trocar to Transducer Tubing 2018-03-29
Synapse Biomedical, Inc.
STERILE Blue Cable Set 2018-03-29
Synapse Biomedical, Inc.
STERILE Lead Tunnelers 2018-03-29
Synapse Biomedical, Inc.
STERILE Indifferent Electrode 2018-03-29
Synapse Biomedical, Inc.
STERILE Mapping Probe 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Surgical Site Start-up Kit 2018-03-29
Synapse Biomedical, Inc.
System Destination Kit, ALS CE 2018-03-29
Synapse Biomedical, Inc.
System Destination Kit, CE 2 EPG 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Patient Kit, 1 EPG 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS Patient Kit 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ Surgical Kit, HDE 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ System Kit, ALS CE 2018-03-29
Synapse Biomedical, Inc.
NeuRx DPS™ System Kit 2018-03-29
Synapse Biomedical, Inc.
NeuRx Diaphragm Pacing System 2018-03-29
SYNAPSE BIOMEDICAL INC.
NeuRx Diaphragm Pacing System2012-11-28
SYNAPSE BIOMEDICAL INC.
NeuRx DPS2012-11-28
SYNAPSE BIOMEDICAL INC.
NeuRx Diaphragm Pacing System2008-12-16
SYNAPSE BIOMEDICAL INC.
NeuRx DPS2008-12-16

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