18 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 2, 2016
Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CIC·August 3, 2016
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
FDA Enforcement
Class II
·Terminated·EKOS Corporation·September 28, 2016
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·December 22, 2015
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·December 22, 2015
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
FDA Recall
Terminated
·Physio-Control, Inc.·Product code MKJ·January 27, 2016