41 results
·
29ms
·
Sources: EU EUDAMED, US FDA
MorTan, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·2 Importers·INTERTEK SEMKO AB
OCULAR IRRIGATION KITS, SINGLE-USE
Device
EU MDD
·
Eu Md Class 2a
·MorTan, Inc.·On the market·19 countries
The Morgan medi-FLOW Lens
FDA UDI
Mortan Inc.·M170MT20000·Ocular irrigation system
The Morgan mor-FLEX Lens
FDA UDI
Mortan Inc.·M170MT66730·Ocular irrigation system
The Morgan mor-FLEX Lens
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·MorTan, Inc.·1 device
41376877-01
Certificate
MDD Annex II (excluding section 4)·MorTan, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI
Medical Workshop BV
Authorized representative
🇳🇱 Netherlands·1 Manufacturer·1 Device
Medical Workshop BV
Importer
🇳🇱 Netherlands·6 Manufacturers
Iogen
Importer
🇫🇮 Finland·25 Manufacturers
ComPAS2
FDA UDI
MORGAN SCIENTIFIC, INC·00851845007170·
ComPAS
FDA UDI
MORGAN SCIENTIFIC, INC·00851845007033·
ComPAS2
FDA UDI
MORGAN SCIENTIFIC, INC·00851845007163·
ComPAS2
FDA UDI
MORGAN SCIENTIFIC, INC·00851845007187·
MORGAN BASIC ONE
FDA Adverse Event
Malfunction
·MORGAN MEDESIGN, INC.·Product code KXJ·May 14, 2021
COMPAS2
FDA Adverse Event
Malfunction
·MORGAN SCIENTIFIC, INC.·Product code BZG·March 20, 2024
TABLE
FDA Adverse Event
Injury
·MORGAN MEDESIGN, INC.·Product code FSE·July 10, 2019
P.K. MORGAN
FDA Adverse Event
Other
·P.K. MORGAN INSTRUMENTS, INC.·August 11, 1993
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·August 15, 2012
Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code frn·March 31, 2009
Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA
FDA Recall
Terminated
·Hospira Inc·Product code frn·March 31, 2009