12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BABY DOPPLEX 4002-TWINS, MODEL BD4002
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 16, 2013
STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 18, 2011
SMARTSITE
FDA Adverse Event
Malfunction
·MEDEX·Product code FPA·June 17, 2008
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·November 6, 2025
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·December 17, 2024
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 17, 2024
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·April 2, 2025
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018