20 results
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23ms
·
Sources: EU EUDAMED, US FDA
MARK II/MARK III MANOMETRIC PERFUSION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003196·1000 micron Holmium Laser Fiber Cable, Reusable...
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464793·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464755·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464786·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464762·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464809·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033464779·
MIZAR, BASIS BE, SANDMAN DIGITAL
FDA 510(k)
FDA Class 2
·Neurology
ELIPAR FREELIGHT
FDA 510(k)
FDA Class 2
·Dental
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2025
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
FDA Enforcement
Class I
·Terminated·Abbott Vascular·May 24, 2017
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
FDA Recall
Terminated
·Abbott Vascular·Product code LOX·March 22, 2017
SYSTEM 7 SINGLE TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·March 20, 2013
ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 12, 2008
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
FDA Enforcement
Class II
·Terminated·Parks Medical Electronics, Inc·December 5, 2012
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