TZ Medical Inc.
FDA Regulatory Profile
TZ Medical Inc. appears in FDA public data with 4 recalls, 15 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0298-2017, Class II) was initiated on July 7, 2016. Its most recent 510(k) clearance was granted on May 22, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 15
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0298-2017 | Class II | Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid contr | July 7, 2016 |
| Z-0293-2016 | Class II | Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath remo | October 14, 2015 |
| Z-0318-2016 | Class II | SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870- | October 14, 2015 |
| Z-1438-2013 | Class II | adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P- | April 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | May 22, 2026 |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | January 10, 2018 |
| K163322 | TZ SKULL PIN Adult | February 23, 2017 |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | June 13, 2011 |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | December 15, 2006 |
| K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | May 11, 2004 |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | April 18, 2003 |
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | December 21, 2000 |
| K993205 | BOOKER BOX, MODEL PAD 5010 | July 20, 2000 |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | September 15, 1999 |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRI | September 15, 1999 |
| K982228 | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 | January 14, 1999 |
| K973132 | EZ HOLD 1 LBS., EZ HOLD 2 LBS | January 12, 1998 |
| K964888 | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II | February 28, 1997 |
| K923930 | ELECTROCARDIOGRAPH TRANSMITTER | October 21, 1992 |