79 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: France
×
ISA VENTILATED 230V
Device
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·On the market·32 countries
ISA Refrigerated 230V
Device
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·On the market·32 countries
Insert Scorpion I-SA
Device
EU MDD
·
Eu Md Class 2a
·SCORPION·On the market·32 countries
ISA Reversible centrifuge, 120V IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
ISA Reversible Centrifuge, 230V IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
ISA Refrigerated Centrifuge, 120V IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
ISA Ventilated Centrifuge, 120V 60Hz
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
ISA Ventilated Centrifuge, 230V IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
ISA Refrigerated Centrifuge, 230V IVD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·AFI Centrifuge·1 device
Insert de détartrage Scorpion I-SA
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·SCORPION·1 device
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
FDA Enforcement
Class II
·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
FDA Enforcement
Class II
·Terminated·Normand-Info S.A.S.U.·June 16, 2021
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
FDA Enforcement
Class II
·Ongoing·Blue Ortho·October 30, 2024
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
FDA Enforcement
Class II
·Terminated·BIOMET FRANCE S.A.R.L.·June 17, 2015
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Enforcement
Class III
·Terminated·Biomerieux·November 26, 2014
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Enforcement
Class I
·Terminated·Biomerieux·December 30, 2015