Medical Device Manufacturer · US , West Linn , OR

Tz Medical, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1992

Total

Cleared

Denied

Tz Medical, Inc. has 14 FDA 510(k) cleared cardiovascular devices. Based in West Linn, US.

Historical record: 14 cleared submissions from 1992 to 2018.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Tz Medical, Inc.

14 devices

1-12 of 14

Cleared Jan 10, 2018

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

K102507 · DSI

Cardiovascular · 285d

Cleared Dec 15, 2006

V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC

K062577 · DSA

Cardiovascular · 106d

Cleared May 11, 2004

NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

K040208 · QSY

General & Plastic Surgery · 102d

Cleared Apr 18, 2003

PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE

K021421 · DRF

Cardiovascular · 350d

Cleared Dec 21, 2000

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01

K001634 · DXH

Cardiovascular · 209d

Cleared Jul 20, 2000

BOOKER BOX, MODEL PAD 5010

K993205 · LDD

Cardiovascular · 300d

Cleared Sep 15, 1999

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

K983196 · DRO

Cardiovascular · 369d

Cleared Sep 15, 1999

PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT...

K983232 · DRO

Cardiovascular · 366d

Cleared Jan 14, 1999

FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25

K982228 · DXH

Cardiovascular · 203d

Cleared Jan 12, 1998

EZ HOLD 1 LBS., EZ HOLD 2 LBS

K973132 · DXC

Cardiovascular · 144d

Tz Medical, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Tz Medical, Inc.

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