16 results
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65ms
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Sources: EU EUDAMED, US FDA
Adaptiiv Medical Technologies Inc.
Manufacturer
🇨🇦 Canada·1 Basic UDI-DI·2 Devices
ADAPTIIV MEDICAL TECHNOLOGIES, INC.
FDA registration
ADAPTIIV MEDICAL TECHNOLOGIES, INC.·1 product·🇨🇦 Canada
3D Bolus Application
Device
EU MDR
·
Eu Md Class 1
·Adaptiiv Medical Technologies Inc.·On the market·3 countries
3D Brachy Application
Device
EU MDR
·
Eu Md Class 1
·Adaptiiv Medical Technologies Inc.·On the market·3 countries
3D Brachy Application
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402326·3D Brachy Software application is indicated for...
3D Bolus Software
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402302·3D Bolus Software is indicated for, and intende...
TrueFit Bolus
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402388·TrueFit Bolus is a 3D printed patient-matched r...
Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU)
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402333·Adaptiiv’s 3D printed patient-matched radiation...
Nova Surface Applicator
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402371·Nova Surface Applicator is a 3D printed patient...
3D Bolus Application
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402319·3D Bolus Software application is indicated for ...
TrueFlex Bolus
FDA UDI
Adaptiiv Medical Technologies Inc·00860007402340·TrueFlex Bolus is a 3D printed patient-matched ...
Adaptiiv Software
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Adaptiiv Medical Technologies Inc.·2 devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MJK·August 28, 2008
LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·July 24, 2008
LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·July 24, 2008