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Sign in to claim this brandTz Medical, Inc.
United States·US-MF-000027311
Last updated September 17, 2026
What Tz Medical, Inc. makes
Tz Medical, Inc. manufactures single-use and reusable medical devices, including conductive skin pads for defibrillation, reusable external defibrillation electrodes for adults, and electrical catheter connection cables. The company also produces telemetric electrocardiographic recorders for ambulatory monitoring, wound compression dressings, bone taps for surgical procedures, and manual femoral artery compression systems. Additional products include vascular puncture haemostasis arm clamps, and titanium distraction pins for orthopedic applications.
The company’s devices are classified under FDA categories including Class I, Class II, Class IIa, Class III, and Class U, with listings in eudamed, FDA 510(k), FDA PMA, and FDA UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 20497, SW TETON AVE, Tualatin, United States
- Website
- www.tzmedical.com
- —
- —
- [email protected]
- Phone
- +1 503 639 0282
- PRRC Contact
- John Lubisich
- EUDAMED SRN
- US-MF-000027311
- FDA FEI Number
- 1000127185
- DUNS Number
- 793149709
Catalogue (153)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EZ-Holder | EZ-Holder | EUDAMED | Class I | Active |
| Clarus Holter | H3R-0039 | EUDAMEDFDA UDI | Class IIa | Active |
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | P200005 | EUDAMEDFDA PMAFDA UDI | Class III | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Tz Medical, Inc. has four FDA recall records initiated between April 30, 2013, and July 7, 2016, all of which are marked as terminated. The recalls involve issues with defibrillation electrodes (potential defective white wire), discrepancies between submitted and filed instructions for use (IFU) for the Neptune Plus and SilverStat pads, and an incorrect label statement ('WITH ANTIMICROBIAL BARRIER') on the Neptune Plus product.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 7, 2016 | Z-0298-2017 | — | terminated | Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label. |
| Oct 14, 2015 | Z-0318-2016 | — | terminated | During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k |
| Oct 14, 2015 | Z-0293-2016 | — | terminated | The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal |
| Apr 30, 2013 | Z-1438-2013 | — | terminated | TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor |