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TZ Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
14
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0298-2017Class IINeptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid contrJuly 7, 2016
Z-0318-2016Class IISilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-October 14, 2015
Z-0293-2016Class IINeptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath remoOctober 14, 2015
Z-1438-2013Class IIadult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-April 30, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K173563ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICEJanuary 10, 2018
K163322TZ SKULL PIN AdultFebruary 23, 2017
K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORJune 13, 2011
K062577V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPCDecember 15, 2006
K040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDMay 11, 2004
K021421PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLEApril 18, 2003
K001634CARDIOSENTRY EVENT MONITOR, MODEL 8470-01December 21, 2000
K993205BOOKER BOX, MODEL PAD 5010July 20, 2000
K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)September 15, 1999
K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRISeptember 15, 1999
K982228FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25January 14, 1999
K973132EZ HOLD 1 LBS., EZ HOLD 2 LBSJanuary 12, 1998
K964888HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS IIFebruary 28, 1997
K923930ELECTROCARDIOGRAPH TRANSMITTEROctober 21, 1992