Tz Medical, Inc.
Tz Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2026, with 4 FDA device recalls on record.
Top product codes for Tz Medical, Inc.
FDA recalls by Tz Medical, Inc.
- Z-0298-2017 — Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
- Z-0293-2016 — Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Z-0318-2016 — SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.
- Z-1438-2013 — adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tz Medical, Inc.
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K173563 — ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
- K163322 — TZ SKULL PIN Adult
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K062577 — V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
- K040208 — NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
- K021421 — PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
- K001634 — CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
- K993205 — BOOKER BOX, MODEL PAD 5010
- K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- K982228 — FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
- K973132 — EZ HOLD 1 LBS., EZ HOLD 2 LBS
- K964888 — HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
- K923930 — ELECTROCARDIOGRAPH TRANSMITTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.