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Tz 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
LinkedIn: —
Facebook: —
Email: [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 3 of 4

Device	Model / Reference	Registries	Class	Status
Pad 1110	PAD 1110	FDA UDI	Class II	Active
Pad 101NHK	PAD 101NHK	FDA UDI	Class II	Active
3-Lead LTE MCT Monitor ZOLL	H3R-0161	FDA UDI	Class II	Active
TZ Medical Titanium Distraction Pins	DP-16-TG	FDA UDI	Class I	Active
Neptune	8870-01	FDA UDI	U	Active
TZ Medical Pressure Discs	8880-04	FDA UDI	Class II	Active
Comfort Band	CB-8514B	FDA UDI	Class I	Active
Comfort Band Non-Sterile 17"	CB-7517P	FDA UDI	Class I	Active
Pad 1115	PAD 1115	FDA UDI	Class II	Active
H3r Clarus Power Supply	H3R-0099	FDA UDI	Class II	Active
14 Pole Catheter Cable	CS-H-14-10	FDA UDI	Class II	Active
Cable, V1-MPC to Electrode – T1 series (Blue/White) (~10ft)	PAD 6099	FDA UDI	Class II	Active
Pad 109	PAD 109	FDA UDI	Class II	Active
TZ Medical Titanium Distraction Pins	DP-12-TB	FDA UDI	Class I	Active
Pad 1112	PAD 1112	FDA UDI	Class II	Active
Neptune ® Pressure Disc with Calcium Alginate Wound Dressing	8880-08	FDA UDI	U	Active
E Neptune Hemostasis Pad	8870-04	FDA UDI	U	Active
Pad 108	PAD 108	FDA UDI	Class II	Active
Cable, Return for RF Stockert 70 Connector (~10ft)	PAD 6061L	FDA UDI	Class II	Active
Comfort Cradle	CZ-001	EUDAMEDFDA UDI	Class I	Active
Cobra Board	CBR-0004	EUDAMEDFDA UDI	Class I	Active
TVA Wrist Strap	CZ-400-WS-TVA	EUDAMED	Class I	Active
TruBrite	ARL-1010	EUDAMEDFDA UDI	Class I	Active
Shoot N See	RCM-005	EUDAMED	Class I	Active
Patient Immobilizer GE	CZ-107	EUDAMED	Class I	Active
Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band	K040208	FDA 510(k)	U	Active
Fm Demodulator-4 Lead Model #8500-05 And Fm Demodulator-12 Lead Model # 8500-25	K982228	FDA 510(k)	Class II	Active
Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable	K021421	FDA 510(k)	Class II	Active
Padtak Pace/Defib/Cardiovert Monitoring Electrode(s)	K983196	FDA 510(k)	Class II	Active
Area-Ct, Tz Medical Mcot Ecg Monitor And Arrhythmia Detector	K102507	FDA 510(k)	Class II	Active
Ez Hold 1 Lbs., Ez Hold 2 Lbs	K973132	FDA 510(k)	Class II	Active
Cardiosentry Event Monitor, Model 8470-01	K001634	FDA 510(k)	Class II	Active
Booker Box, Model Pad 5010	K993205	FDA 510(k)	Class II	Active
Arc Adjustable Radial Cuff Compression Device	K173563	FDA 510(k)	Class II	Active
Heart Aide Multple/Heart Aide Plus/Heart Aide Plus Ii	K964888	FDA 510(k)	Class II	Active
V1 Multi-Port Connector, Model Pad V1-Mpc	K062577	FDA 510(k)	Class II	Active
Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2x2.25), Model 2602, Padtak Pediatric Defib/Cardiovert	K983232	FDA 510(k)	Class II	Active
Electrocardiograph Transmitter	K923930	FDA 510(k)	Class II	Active
TZ SKULL PIN Adult	K163322	FDA 510(k)	Class II	Active
Wrist Strap	CZ-008	EUDAMED	Class I	Active
ARC Sterile Radial Compression Device	RCB-0047	EUDAMEDFDA UDI	Class I	Active
Patient Immobilizer Extender	CZ-012	EUDAMED	Class I	Active
Radial Runway	RRU-0008	EUDAMEDFDA UDI	Class I	Active
ARC Sterile Radial Compression Device	RCB-0048	EUDAMEDFDA UDI	Class I	Active
Radial Arm Board	CZ-400	EUDAMED	Class I	Active
TVA Radial Arm Board	CZ-400-TVA	EUDAMED	Class I	Active
Patient Immobilizer	CZ-106	EUDAMED	Class I	Active
Radial Runway Top Pad Assembly	RRU-0009	EUDAMEDFDA UDI	Class I	Active
Comfort Cradle Polypropylene	CZ-001-PP	EUDAMED	Class I	Active
ARC Sterile Radial Compression Device	RCB-0049	EUDAMEDFDA UDI	Class I	Active

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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.

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