5,146 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
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
FDA Recall
Terminated
·TZ Medical, Inc.·Product code FRO·July 7, 2016
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.
FDA Recall
Terminated
·TZ Medical Inc.·Product code DRO·April 30, 2013
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.
FDA Recall
Terminated
·TZ Medical Inc.·Product code FRO·October 14, 2015
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
FDA Recall
Terminated
·TZ Medical Inc.·Product code FRO·October 14, 2015
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Recall
Terminated
·Hologic, Inc·Product code NSU·August 4, 2020