15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIVA LUTING PLUS
FDA 510(k)
FDA Class 2
·Dental
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 8, 2019
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0620650·6mm H x 20mm W x 65mm L x 0 degrees XLIF
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036026080·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X062065120·6mm H x 20mm W x 65mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062065120·6mm H x 20mm W x 65mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06206580·6mm H x 20mm W x 65mm L x 8 degrees XLIF
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
FDA 510(k)
FDA Class 1
·General Hospital
WIENER LAB. CREATININA CINETICA AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·April 16, 2013
PERFORATOR BIT LARGE 14/11MM
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code HBF·March 16, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 4, 2014
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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