12 results · 21ms · Sources: EU EUDAMED, 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