9 results · 36ms · Sources: EU EUDAMED, US FDA

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ACON TRI-FECT DRUG SCREEN TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CLINICSELECT Blue X-ray Film

FDA UDI
CARESTREAM HEALTH, INC.·40889976041747·CS BLUE X-RAY FILM 35X43-14X17 100SH

(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW

FDA 510(k)
FDA Class 1 ·General Hospital

ULTIMA SMARTBELT, MODEL 0560

FDA 510(k)
FDA Class 2 ·Anesthesiology

2520274-2013-01870

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·April 8, 2013

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·March 29, 2011

VITALITY DS VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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