BEUDAMED
    396 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code EMF·May 3, 2013

    Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

    Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·December 13, 2011

    NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

    FDA Recall
    Terminated ·Hill-Rom Inc.·Product code KMI·February 14, 2020

    Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820 A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code KMI·August 8, 2008

    MAC-LAB 3000EX systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    MAC-LAB 5000EX systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. For use in reducing patient falls.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·November 25, 2009

    CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.

    FDA Recall
    Terminated ·Curbell Medical, Inc.·Product code KMI·August 5, 2014

    Tabs Professional Monitor Without Wall Bracket, Model 25023. Stanley Senior Technologies, Lincoln, NE.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·March 26, 2010

    Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.

    FDA Recall
    Terminated ·AliMed Corporation·Product code KMI·February 12, 2010

    Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley Senior Technologies, Lincoln, NE.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·March 26, 2010

    Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·March 26, 2010

    Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·May 4, 2012

    QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code KMI·December 16, 2012