12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANA SCREEN ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
VARIAX
FDA UDI
Stryker GmbH·07613327177091·Silicone Mat
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
FDA 510(k)
FDA Class 2
·Ophthalmic
DIAPHARMA FACTOR X KIT
FDA 510(k)
FDA Class 2
·Hematology
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
PIONEER MATTRESS 30"
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code IKY·December 9, 2010
VALLEYLAB
FDA Adverse Event
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE·Product code JOS·July 11, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020