Home › Device types › OIR
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
FDA product code OIR · Class 3 · Unknown
53
Registered devices
23
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Clinical Station Kit — Synapse Biomedical, Inc.STERILE Trocar to Transducer Tubing — Synapse Biomedical, Inc.NeuRx DPS Patient Kit — Synapse Biomedical, Inc.Surface Electrode, 4-pack with Interconnect — Synapse Biomedical, Inc.NeuRx DPS™ Clinical Station Kit, HDE — Synapse Biomedical, Inc.STERILE Touchproof Cable, White — Synapse Biomedical, Inc.Socket Pusher — Synapse Biomedical, Inc.STERILE PermaLoc Electrode, 60cm — Synapse Biomedical, Inc.NeuRx DPS™ Surgical Kit — Synapse Biomedical, Inc.Airline Travel Battery Pack — Synapse Biomedical, Inc.Clinical Station — Synapse Biomedical, Inc.Surface Electrode, Single-Pack — Synapse Biomedical, Inc.NeuRx DPS™ Pacing System, European CE Patient Kit — Synapse Biomedical, Inc.NeuRx DPS™ Surgical Kit, HDE — Synapse Biomedical, Inc.Clinical Station Kit, ALS HDE — Synapse Biomedical, Inc.System Destination Kit, SCI HDE, US — Synapse Biomedical, Inc.NeuRx DPS™ System Kit, Canada — Synapse Biomedical, Inc.System Destination Kit, CE 2 EPG — Synapse Biomedical, Inc.Surgical Connector Kit — Synapse Biomedical, Inc.Silicone Adhesive Kit — Synapse Biomedical, Inc.Connector Holder Kit — Synapse Biomedical, Inc.STERILE Lead Tunnelers — Synapse Biomedical, Inc.NeuRx DPS™ Surgical Site Start-up Kit — Synapse Biomedical, Inc.Patient Cable — Synapse Biomedical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-11 | Synapse Biomedical Inc | Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potent |
| 2022-05-31 | Synapse Biomedical Inc | Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is inten |
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