11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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GALILEO GOLD ASV
FDA 510(k)
FDA Class 2
·Anesthesiology
RAPHAEL COLOR ASV VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Metoxit AG
Manufacturer
🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices
Liquid
Device
EU MDR
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Eu Md Class 2a
·Metoxit AG·On the market·5 countries
Z-CAD Blank
Device
EU MDR
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Eu Md Class 2a
·Metoxit AG·On the market·5 countries
HAMILTON-C6, REF: 160021
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·May 3, 2023
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Enforcement
Class II
·Terminated·BD SWITZERLAND SARL·May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Enforcement
Class II
·Terminated·BD SWITZERLAND SARL·May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
FDA Enforcement
Class II
·Terminated·BD SWITZERLAND SARL·May 20, 2020
Z-CAD Liquid
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Metoxit AG·1 device
Z-CAD Blank
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Metoxit AG·1 device