14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CS 8100SC, CS8100SC Access
FDA 510(k)
FDA Class 2
·Dental
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304241039·
REPROCESSED RESTEP COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA INTEGRATED SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COCR FEMORAL BALL HEAD Ø 32 S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 25, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
SMARTSET MV ENDURANCE 80G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·June 30, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
EASYLINK
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016