11 results
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19ms
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Sources: EU EUDAMED, US FDA
LEKSELL GAMMAPLAN
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496061540·FREE LEGS, SIZE L, NERO, MICRO-MASSAGING ANTI-C...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20615401·Arch wires Titanol Budget mand. .016"x.016"
Rapr-Round
FDA UDI
STRYKER CORPORATION·07613327175073·
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
FDA 510(k)
FDA Class 2
·Cardiovascular
RUSCH EDGAR TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 27, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2008
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 18, 2011
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