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.
| Registration Number | 3005868392 |
| FEI Number | 3005868392 |
| Name | SYNAPSE BIOMEDICAL INC. |
| Owner & Operator | Synapse Biomedical Inc. |
| Contact Address | 300 Artino Street Oberlin OH 44074 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 300 Artino Street Oberlin, OH 44074 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| 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 System | 2012-11-28 |
SYNAPSE BIOMEDICAL INC. | NeuRx DPS | 2012-11-28 |
SYNAPSE BIOMEDICAL INC. | NeuRx Diaphragm Pacing System | 2008-12-16 |
SYNAPSE BIOMEDICAL INC. | NeuRx DPS | 2008-12-16 |
| NCAGE Code | 43DA5 | SYNAPSE BIOMEDICAL INC!DBA SYNAPSE BIOMEDICAL |
| CAGE Code | 43DA5 | SYNAPSE BIOMEDICAL INC SYNAPSE BIOMEDICAL |
| S.A.M. Registration | 43DA5 [138432070] | SYNAPSE BIOMEDICAL INC SYNAPSE BIOMEDICAL |
| SEC | 0001273829 | SYNAPSE BIOMEDICAL INC of DELAWARE |