Company ยท US
Tz Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 3 |
| DXC | Clamp, Vascular | 3 |
| FRO | Dressing, Wound, Drug | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 |
| PFJ | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K262570 | TZ Medical Birthing Balloon Kit TZ Medical | PFJ |
| May 22, 2026 | K252772 | Arc Adjustable Radial Cuff Compression Device Tz Medical, Inc. | DXC |
| Jan 10, 2018 | K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE Tz Medical, Inc. | DXC |
| Feb 23, 2017 | K163322 | TZ SKULL PIN Adult Tz Medical, Inc. | HBL |
| Jun 13, 2011 | K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR Tz Medical, Inc. | DSI |
| Dec 15, 2006 | K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC Tz Medical, Inc. | DSA |
| May 11, 2004 | K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND Tz Medical, Inc. | QSY |
| Apr 18, 2003 | K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE Tz Medical, Inc. | DRF |
| Dec 21, 2000 | K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 Tz Medical, Inc. | DXH |
| Jul 20, 2000 | K993205 | BOOKER BOX, MODEL PAD 5010 Tz Medical, Inc. | LDD |
| Sep 15, 1999 | K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT Tz Medical, Inc. | DRO |
| Sep 15, 1999 | K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) Tz Medical, Inc. | DRO |
| Jan 14, 1999 | K982228 | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 Tz Medical, Inc. | DXH |
| Jan 12, 1998 | K973132 | EZ HOLD 1 LBS., EZ HOLD 2 LBS Tz Medical, Inc. | DXC |
| Feb 28, 1997 | K964888 | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II Tz Medical, Inc. | DXH |
| Oct 21, 1992 | K923930 | ELECTROCARDIOGRAPH TRANSMITTER Tz Medical, Inc. | DXH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | TZ Medical, Inc. 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 Terminated |
FRO | K040208 |
| Oct 14, 2015 | TZ Medical Inc. Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 Terminated |
FRO | K071442 |
| Oct 14, 2015 | TZ Medical Inc. 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 h Terminated |
FRO | None listed |
| May 30, 2013 | TZ Medical Inc. 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 M Terminated |
DRO | K983196 |