19 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUXAGLAZE
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450465455·
FRYE & CO
FDA UDI
FGX INTERNATIONAL INC.·00193033474563·
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BASIX COMPAK INFLATION SYRINGE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011
PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 REGULAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 20, 2013
HALF DAY INFUSOR, 5ML/HR 12PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 12, 2008
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSD·March 27, 2018
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016