TZ Medical Inc.
Tualatin, OR, US
TZ MEDICAL, INC. appears in FDA device records in Tualatin, OR. FDA records list 15 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for TZ Medical Inc. between 1992 and 2026. The busiest year on record is 1999, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | DXC | Substantially Equivalent | |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | DXC | Substantially Equivalent | |
| K163322 | TZ SKULL PIN Adult | HBL | Substantially Equivalent | |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | DSI | Substantially Equivalent | |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | DSA | Substantially Equivalent | |
| K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | QSY | Substantially Equivalent | |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | DRF | Substantially Equivalent | |
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | DXH | Substantially Equivalent | |
| K993205 | BOOKER BOX, MODEL PAD 5010 | LDD | Substantially Equivalent | |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | DRO | Substantially Equivalent | |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | DRO | Substantially Equivalent | |
| K982228 | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 | DXH | Substantially Equivalent | |
| K973132 | EZ HOLD 1 LBS., EZ HOLD 2 LBS | DXC | Substantially Equivalent | |
| K964888 | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II | DXH | Substantially Equivalent | |
| K923930 | ELECTROCARDIOGRAPH TRANSMITTER | DXH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027815 | 1000127185 | TZ MEDICAL, INC. | 20497 Sw Teton Ave, Tualatin, OR 97062 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- IWOApron, Protective
- MKJAutomated External Defibrillators (Non-Wearable)
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DXCClamp, Vascular
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- KMKDevice, Intravascular Catheter Securement
- MHWDressing, Compression
- FRODressing, Wound, Drug
- LDFElectrode, Pacemaker, Temporary
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- EYJHolder, Ureteral Catheter
- KDCInstrument, Surgical, Disposable
- DYBIntroducer, Catheter
- KMIMonitor, Bed Patient
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- IWPRadiographic Protective Glove
- GADRetractor
- KPYShield, Protective, Personnel
- CCXSupport, Patient Position
- MAVSyringe, Balloon Inflation
- BWNTable And Attachments, Operating-Room
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- HXTTape, Orthopedic
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRCTrocar
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0298-2017 | Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy | Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label. | Class II | Terminated | |
| Z-0293-2016 | Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 | 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 | Class II | Terminated | |
| Z-0318-2016 | SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only. | 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 | Class II | Terminated | |
| Z-1438-2013 | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring. | 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 | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain