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Sign in to claim this brandTz Medical, Inc.
United States·US-MF-000027311
Last updated September 17, 2026
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 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arc Adjustable Radial Cuff Compression Device | K252772 | FDA 510(k) | Class II | Active |
| Pad 101pd | PAD 101PD | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-111-K1 | FDA UDI | Class II | Active |
| Cable, Bifurcated, Return for RF to ESU Connector Stockert 70 (EPT) (~10ft) | PAD 6063LB | FDA UDI | Class II | Active |
| Cable, V1-MPC to Defibrillator/Pacemaker –Medtronic/Quick Combo (~10ft) | PAD 6081 | FDA UDI | Class II | Active |
| Pad 1115z | PAD 1115Z | FDA UDI | Class II | Active |
| Pad 1122 | PAD 1122 | FDA UDI | Class II | Active |
| Comfort Band Non-Sterile 14" | CB-7514B | FDA UDI | Class I | Active |
| Trident 40M | H3R-0040 | FDA UDI | Class II | Active |
| H3R Holster | H3R-0027 | FDA UDI | Class II | Active |
| Cable, Extension for Unipolar Recording (~10ft) | PAD 6066 | FDA UDI | Class II | Active |
| TZ Medical Titanium Distraction Pins | DP-18-TP | FDA UDI | Class I | Active |
| Defibrillation Electrodes | P-212-Z1 | FDA UDI | Class II | Active |
| Pad 3020-Qc | PAD 3020-QC | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-211-T1 | FDA UDI | Class II | Active |
| Cable, V1-MPC to Defibrillator/Pacemaker – Zoll (~10ft) | PAD 6080 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-111-P1 | FDA UDI | Class II | Active |
| Comfort Band Non-Sterile 20" | CB-7520G | FDA UDI | Class I | Active |
| Pad 3010-Xlt | PAD 3010-XLT | FDA UDI | Class II | Active |
| Pad 101pdl | PAD 101PDL | FDA UDI | Class II | Active |
| Cable, V1-MPC to Defibrillator/Pacemaker – Phillips (Grey/Flat) (~10ft) | PAD 6083 | FDA UDI | Class II | Active |
| H3r Wall Charger (zoll) | H3R-0155 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-112-T1 | FDA UDI | Class II | Active |
| Trident Charge Only Multi Bay Dock | H3R-0182 | FDA UDI | Class II | Active |
| Gang Charger for 9 Holter Devices | H3R-0073 | FDA UDI | Class II | Active |
| Pad 1113 | PAD 1113 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-211-Z1 | FDA UDI | Class II | Active |
| TZ Medical Pressure Discs | 8880-06 | FDA UDI | Class II | Active |
| H3R Cable 3 lead | H3R-0169 | FDA UDI | Class II | Active |
| Pad 3010-Zmi | PAD 3010-ZMI | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-211-M1 | FDA UDI | Class II | Active |
| Pad 3010hp | PAD 3010HP | FDA UDI | Class II | Active |
| Cable, V1-MPC to Defibrillator/Pacemaker – Phillips (White Barrel/Twist lock (~1 | PAD 6082 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-212-M1 | FDA UDI | Class II | Active |
| Biotronik Neptune | 8870-02 | FDA UDI | U | Active |
| Pad 3010-Qc | PAD 3010-QC | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-121-T1 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-111-T1K | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-111-T1 | FDA UDI | Class II | Active |
| Pad 1110z | PAD 1110Z | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-211-K1 | FDA UDI | Class II | Active |
| EZ Hold | 8260-20 | FDA UDI | Class II | Active |
| Pad 1111 | PAD 1111 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-311-Z1 | FDA UDI | Class II | Active |
| Pad 3020-Hp | PAD 3020-HP | FDA UDI | Class II | Active |
| 4 Lead Holter Cable | H3R-0077 | FDA UDI | Class II | Active |
| Defibrillation Electrodes | P-214-Z1 | FDA UDI | Class II | Active |
| V1-MPC Booker Box System | V1-MPC | FDA UDI | Class II | Active |
| Pad 1115c | PAD 1115C | FDA UDI | Class II | Active |
| Skull Pins | SP-001 | FDA UDI | Class II | Active |
Related Companies
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- CEpartner4U NL
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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.
| 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 |