FDA.reportPublic FDA data

TZ MEDICAL, INC.

Matched from indexed company URL: TZ Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30278151000127185TZ MEDICAL, INC.1N2026-01-0120497 Sw Teton Ave Tualatin OR US 97062

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
460581149691034P200005TZ Medical Defibrillation Electrodes, Accessory Cables, and ConnectorsMKJ2024-01-09
460581906880945K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTDRO1999-09-15
460581258609785K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)DRO1999-09-15
460581705501465K982228FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25DXH1999-01-14
460581093001364K973132EZ HOLD 1 LBS., EZ HOLD 2 LBSDXC1998-01-12
460581724976866K964888HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS IIDXH1997-02-28
460581855616308K923930ELECTROCARDIOGRAPH TRANSMITTERDXH1992-10-21
460581716324419K923085QUICKLAMP SYSTEMDXC1993-02-12
460581033955647K914149FEMORAL ARTERY PRESSURE PAD/DISKDXC1991-12-13
460581387746829K242248Introducer Sheath KitsDYB2024-08-22
460581946236363K173563ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICEDXC2018-01-10
460581996469316K163322TZ SKULL PIN AdultHBL2017-02-23
460581386762346K140943MASTRO PLUS BALLOON IN-DEFLATION DEVICEMAV2015-03-05
460581922646576K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORDSI2011-06-13
460581984433709K062577V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPCDSA2006-12-15
460581360696501K053590SILVERLON CA (CALCIUM ALGINATE)FRO2006-10-06
460581842566221K040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDQSY2004-05-11
460581578530630K021421PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLEDRF2003-04-18
460581564517132K011727TRANSSEPTAL NEEDLE/TROCARDRC2002-05-02
460581784133278K001634CARDIOSENTRY EVENT MONITOR, MODEL 8470-01DXH2000-12-21
460581056568887
460581016487118
460581034283988
460581084114176
460581112704513
460581123129101
460581193998503
460581274719725
460581504690078
460581534169012
460581594189242
460581726238258
460581729813120
460581746684053
460581802592075
460581861531904
460581963550512

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXC42018-01-10
DXH42000-12-21
DRO21999-09-15
DYB12024-08-22
HBL12017-02-23
MAV12015-03-05
DSI12011-06-13
DSA12006-12-15
FRO12006-10-06
QSY12004-05-11
DRF12003-04-18
DRC12002-05-02

PMN#

GUDID#

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