Data / Medical devices / United States / TZ Medical, Inc.

TZ Medical, Inc.: FDA-registered device maker in Tualatin, OR, United States, 18 510(k) clearances and 1 PMA approval

Name: TZ Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TZ Medical, Inc. is registered with the FDA (registration 3027815) in Tualatin, OR, United States. It lists 29 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated August 22, 2024. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3027815
FEI number: 1000127185
Address: 20497 Sw Teton Ave, Tualatin, OR, United States, 97062
Owner or operator: TZ MEDICAL, INC. (9006202)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: February 25, 2002
Registered through: 2027
Brand names listed: AD-SKIN, ARC Band, ATS, AccuFlate Inflation Device, Adaptable Tensioning System, Aera, Aera CT, Anti-Fatigue Floor Mat and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Repackager or relabeler	accessdata.fda.gov
Apron, Protective	IWO	1	Repackager or relabeler	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Specification developer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer, Specification developer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Manufacturer, Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical Patient Return Electrode	ODR	2	Repackager or relabeler	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Manufacturer, Specification developer	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Manufacturer, Specification developer	accessdata.fda.gov
Holder, Ureteral Catheter	EYJ	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer, Specification developer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Radiographic Protective Glove	IWP	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Manufacturer, Specification developer	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer, Specification developer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Repackager or relabeler	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Manufacturer, Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer, Specification developer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer, Specification developer	accessdata.fda.gov
Tape, Orthopedic	HXT	1	Repackager or relabeler	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Manufacturer, Specification developer	accessdata.fda.gov
Trocar	DRC	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 22, 2024	K242248	Introducer Sheath Kits	DYB	Substantially Equivalent	Beijing Demax Medical Technology Co.,Ltd	accessdata.fda.gov
January 10, 2018	K173563	ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE	DXC	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
February 23, 2017	K163322	TZ SKULL PIN Adult	HBL	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
August 19, 2016	K160366	Electrosurgical disposable grounding pads	ODR	Substantially Equivalent	Top-Rank Health Care Co., Ltd.	accessdata.fda.gov
March 5, 2015	K140943	MASTRO PLUS BALLOON IN-DEFLATION DEVICE	MAV	Substantially Equivalent	Beijing Demax Medical Technology Co.,Ltd	accessdata.fda.gov
June 13, 2011	K102507	AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR	DSI	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
December 15, 2006	K062577	V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC	DSA	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
October 6, 2006	K053590	SILVERLON CA (CALCIUM ALGINATE)	FRO	Substantially Equivalent	Argentum Medical, LLC	accessdata.fda.gov
May 11, 2004	K040208	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	QSY	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
April 18, 2003	K021421	PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE	DRF	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
May 2, 2002	K011727	TRANSSEPTAL NEEDLE/TROCAR	DRC	Substantially Equivalent	Thomas Medical Products, Inc.	accessdata.fda.gov
December 21, 2000	K001634	CARDIOSENTRY EVENT MONITOR, MODEL 8470-01	DXH	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
January 14, 1999	K982228	FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25	DXH	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
January 12, 1998	K973132	EZ HOLD 1 LBS., EZ HOLD 2 LBS	DXC	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
February 28, 1997	K964888	HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II	DXH	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
February 12, 1993	K923085	QUICKLAMP SYSTEM	DXC	Substantially Equivalent	Disco, Inc.	accessdata.fda.gov
October 21, 1992	K923930	ELECTROCARDIOGRAPH TRANSMITTER	DXH	Substantially Equivalent	Tz Medical, Inc.	accessdata.fda.gov
December 13, 1991	K914149	FEMORAL ARTERY PRESSURE PAD/DISK	DXC	Substantially Equivalent	Disco, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
January 9, 2024	P200005	TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors	MKJ	0	January 9, 2024	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 7, 2016	74809	Class II	Terminated	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.	Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.	accessdata.fda.gov
October 14, 2015	72451	Class II	Terminated	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	accessdata.fda.gov
October 14, 2015	72450	Class II	Terminated	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 an	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	accessdata.fda.gov
April 30, 2013	65120	Class II	Terminated	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 a	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	accessdata.fda.gov

Compare with other makers

Updated August 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.