Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027815

FEI Number

1000127185

Entity Name

TZ MEDICAL, INC.

City/State/Country

Tualatin, OR, US

Establishment Address

20497 Sw Teton Ave, Tualatin, OR 97062, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

TZ MEDICAL, INC. (Owner Number: 9006202)

Owner / Operator Contact Address

20497 SW Teton Avenue, Suite A, --, Tualatin, OR 97062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SilverStat ATS Adaptable Tensioning System TZ Thin-Wall Radial Sheath Shoot'N"See CS-H-14-10 - Cable CF-D7-AAA-NSDA Comfort Shield Radiation Attenuation Headband Flipper HALO FLIPPER URPRO PERIPHERAL FLIPPER EZ Holder TZ Distraction Pin RADIAL RUNWAY Apron Leaded Vest Leaded Thiroid Colar AD-SKIN Skull Pin Adult Radiation Protective Gloves IDD-0020 IDD-0010 PTCA Kit AccuFlate Inflation Device QuicKlamp P-122-T1, Sterile P-214-Z1, Zoll P-224-Z1, Zoll, Sterile P-224-T1, Sterile P-214-M1, Medtronic P-214-T1 P-311-T1 Multi-Function Defibrillator Electrodes Adult P-212-Z1, Zoll P-111-Z1, Zoll P-211-M1, Medtronic P-111-M1, Medtronic P-122-Z1 , Zoll, Sterile Multi-Function Defibrillator Electrodes Adult - Sterile P-311-M1, Medtronic P-121-Z1, Zoll, Sterile P-212-M1, Medtronic P-311-Z1, Zoll Multi-Function Defibrillator Electrodes Pediatric Multi-Function Defibrillator Electrodes Pediatric - Sterile P-112-T1 P-211-Z1, Zoll P-111-T1 P-211-T1 Defibrillation Electrodes P-121-T1, Sterile TruBrite Heart Aide ARC Band Comfort Band Radial Comfort Band Radial Adjustable Comfort Band EZ BAND ROC Band TZ Disc TZ Pressure Dics EZ HOLD EZ Pace Ultra Pace Aera LifeSense Clarus 40 Aera CT Trident Nano Trident Pro Trident Holter Trident 30 Trident 40 LTE CARDIOSENTRY PULLIE Pannus Retention System (PRS) Panni XL (PPR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-10-06
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-12-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-12-08
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2018-01-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2006-06-19
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2011-08-11
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2017-07-18
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-02-21
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-11-05
IWO	Apron, Protective	Radiology	Class 1	892.6500	2015-10-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-02-21
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2022-09-30
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2015-10-06
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2021-08-31
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2020-09-04
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2009-04-02
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-06-11
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-04-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-10-06
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2007-10-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2023-12-18
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2002-02-25
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2011-05-27
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-11-09
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2011-08-11
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2011-08-11
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2007-11-09
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2026-02-18

Official Correspondent

John Lubisich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TZ MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027815. Last updated year: 2026. Please use registration number 3027815 when referencing this establishment in official correspondence.