28 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
FDA Enforcement
Class I
·Ongoing·North Coast Medical Inc·October 6, 2021
The Tri-Flo Subglottic Suction System
FDA Enforcement
Class I
·Terminated·Vyaire Medical·August 29, 2018
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020
HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 19, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 30, 2020