TZ MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3027815	1000127185	TZ MEDICAL, INC.	1	N	2026-01-01	20497 Sw Teton Ave Tualatin OR US 97062

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
46058	1149691034	P200005	TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors	MKJ	2024-01-09
46058	1906880945	K983232	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT	DRO	1999-09-15
46058	1258609785	K983196	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	DRO	1999-09-15
46058	1705501465	K982228	FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25	DXH	1999-01-14
46058	1093001364	K973132	EZ HOLD 1 LBS., EZ HOLD 2 LBS	DXC	1998-01-12
46058	1724976866	K964888	HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II	DXH	1997-02-28
46058	1855616308	K923930	ELECTROCARDIOGRAPH TRANSMITTER	DXH	1992-10-21
46058	1716324419	K923085	QUICKLAMP SYSTEM	DXC	1993-02-12
46058	1033955647	K914149	FEMORAL ARTERY PRESSURE PAD/DISK	DXC	1991-12-13
46058	1387746829	K242248	Introducer Sheath Kits	DYB	2024-08-22
46058	1946236363	K173563	ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE	DXC	2018-01-10
46058	1996469316	K163322	TZ SKULL PIN Adult	HBL	2017-02-23
46058	1386762346	K140943	MASTRO PLUS BALLOON IN-DEFLATION DEVICE	MAV	2015-03-05
46058	1922646576	K102507	AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR	DSI	2011-06-13
46058	1984433709	K062577	V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC	DSA	2006-12-15
46058	1360696501	K053590	SILVERLON CA (CALCIUM ALGINATE)	FRO	2006-10-06
46058	1842566221	K040208	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	QSY	2004-05-11
46058	1578530630	K021421	PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE	DRF	2003-04-18
46058	1564517132	K011727	TRANSSEPTAL NEEDLE/TROCAR	DRC	2002-05-02
46058	1784133278	K001634	CARDIOSENTRY EVENT MONITOR, MODEL 8470-01	DXH	2000-12-21
46058	1056568887
46058	1016487118
46058	1034283988
46058	1084114176
46058	1112704513
46058	1123129101
46058	1193998503
46058	1274719725
46058	1504690078
46058	1534169012
46058	1594189242
46058	1726238258
46058	1729813120
46058	1746684053
46058	1802592075
46058	1861531904
46058	1963550512

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DXC	4	2018-01-10
DXH	4	2000-12-21
DRO	2	1999-09-15
DYB	1	2024-08-22
HBL	1	2017-02-23
MAV	1	2015-03-05
DSI	1	2011-06-13
DSA	1	2006-12-15
FRO	1	2006-10-06
QSY	1	2004-05-11
DRF	1	2003-04-18
DRC	1	2002-05-02

PMN#

AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
2011-06-13
TZ MEDICAL, INC.
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
2006-12-15
TZ MEDICAL, INC.
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
2004-05-11
TZ MEDICAL, INC.
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
2003-04-18
TZ MEDICAL, INC.
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
2000-12-21
TZ MEDICAL, INC.
BOOKER BOX, MODEL PAD 5010
2000-07-20
TZ MEDICAL, INC.
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
1999-09-15
TZ MEDICAL, INC.
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
1999-09-15
TZ MEDICAL, INC.
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
1999-01-14
TZ MEDICAL, INC.
EZ HOLD 1 LBS., EZ HOLD 2 LBS
1998-01-12
TZ MEDICAL, INC.
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
1997-02-28
TZ MEDICAL, INC.
ELECTROCARDIOGRAPH TRANSMITTER
1992-10-21
TZ MEDICAL, INC.

GUDID#

Retractor Distractor - Right alignment distractor
Tz Medical, Inc.
2025-02-12
Retractor Distractor - Left alignment distractor
Tz Medical, Inc.
2025-02-12
EZ Holder - CT-0010
Tz Medical, Inc.
2023-10-20
ARC Adjustable Radial Cuff - ARC Adjustable Radial Cuff- Medium
Tz Medical, Inc.
2023-11-15
ARC Adjustable Radial Cuff - ARC Adjustable Radial Cuff- Large
Tz Medical, Inc.
2023-11-15
ARC Adjustable Radial Cuff - ARC Adjustable Radial Cuff- Small
Tz Medical, Inc.
2023-11-15
ARC Adjustable Radial Cuff - ARC Adjustable Radial Cuff- Large
Tz Medical, Inc.
2023-11-15
ARC Adjustable Radial Cuff - ARC Adjustable Radial Cuff- Small
Tz Medical, Inc.
2023-11-15
H3R USB Cable - H3R-0025
Tz Medical, Inc.
2023-11-15
H3R Holster - H3R Holster (Rev A)
Tz Medical, Inc.
2023-11-15
Comfort Band - Comfort Band, Sterile, 14” – Blue
Tz Medical, Inc.
2023-10-20
Comfort Band - Comfort Band, Sterile, 17” – Purple
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Round Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Oval Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Round Universal Disc
Tz Medical, Inc.
2023-10-20
TruBrite Adhesive Retractor Light - Adhesive Retractor Light
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Oval Universal Disc
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Large Round Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Round Universal Disc
Tz Medical, Inc.
2023-10-20
EZ Holder - CT-0010
Tz Medical, Inc.
2023-10-20
TruBrite Adhesive Retractor Light - Adhesive Retractor Light
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Oval Universal Disc
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Large Round Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
Trident 3-Lead Cable - Trident™ 40 3-Electrode Cable
Tz Medical, Inc.
2023-10-20
Comfort Band - Comfort Band, Sterile, 14” – Blue
Tz Medical, Inc.
2023-10-20
Comfort Band - Comfort Band, Sterile, 17” – Purple
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Round Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
TZ Medical Pressure Discs - Oval Universal Disc w/ Omega opening
Tz Medical, Inc.
2023-10-20
Neptune Comfort Band - Comfort-Band – Sterile w/Alginate – 14 inch, Blue
Tz Medical, Inc.
2023-10-16
Neptune ® Comfort Band with Calcium Alginate Wound Dressing - Neptune ® Comfort Band with Calcium Alginate Wound Dressing 17 inch Sterile
Tz Medical, Inc.
2023-10-16
Neptune ® Pressure Disc with Calcium Alginate Wound Dressing - Neptune ® Round Pressure Disc with Calcium Alginate Wound Dressing
Tz Medical, Inc.
2023-10-16
Neptune Oval Pressure Disc - 8880-07
Tz Medical, Inc.
2023-10-16
E Neptune Hemostasis Pad - 8870-04
Tz Medical, Inc.
2023-10-16
Neptune - Neptune 2x2 hemostatic pad
Tz Medical, Inc.
2023-10-16
Neptune Plus Calcium Alginate Pad - 8870-03
Tz Medical, Inc.
2023-10-16
Skull Pins - Stainless Steel Skull Pin
Tz Medical, Inc.
2023-10-16
Biotronik Neptune - Biotronik Neptune Pad
Tz Medical, Inc.
2023-10-16
Neptune - Neptune 2x2 hemostatic pad
Tz Medical, Inc.
2023-10-16
Neptune Plus Calcium Alginate Pad - 8870-03
Tz Medical, Inc.
2023-10-16
Skull Pins - Stainless Steel Skull Pin
Tz Medical, Inc.
2023-10-16

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