17 results
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25ms
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Sources: EU EUDAMED, US FDA
PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
FDA 510(k)
FDA Class 2
·Dental
INTERSTIM®
FDA UDI
MEDTRONIC, INC.·20613994145066·CABLE 041831 INTERSTIM 6PK PAT SCNR
INTERSTIM®
FDA UDI
MEDTRONIC, INC.·20763000060286·CABLE 041831 PAT SCREEN INTERSTIM US
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLELESS TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
MULTI-LINK RX PIXEL CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·GUIDANT VASCULAR INTERVENTION·Product code MAF·August 10, 2006
LCP DISTTIBPL2.7/3.5 MED R SHAFT 8HO TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 6, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
TPRLC 133 T1 PPS HO 11X142MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·April 1, 2025
TLOC 133 MP SP T1 PPSHO 6X97.5
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 1, 2025
TPRLC 133 MP TYPE1 PPS HO 17.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 1, 2025
TPRLC 133 FP TYPE1 PPS SO 4.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 1, 2025
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, 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
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018