18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 150mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009941·
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933486·Percutaneous Transluminal Angioplasty Balloon C...
Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795009593·BOW & Arrow Cotton Plate, 5mm Wedge
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934094·Percutaneous Transluminal Angioplasty Balloon C...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175375·Z-Rod, Dia. 5.5mm, Co-Cr, 150mm
Toilet Support Arms
FDA UDI
Ropox A/S·05707581000355·
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
FDA 510(k)
FDA Class 2
·Neurology
CRC-15BT
FDA 510(k)
FDA Class 2
·Radiology
VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 20, 2013
PROCLEAR MULTIFOCAL CONTACT LENSES
FDA Adverse Event
Injury
·COOOPERVISION·Product code LPL·April 5, 2013
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·April 5, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 9, 2008
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 7, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018