132 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
Pro-Flo™
FDA UDI
MEDTRONIC, INC.·00613994944092·CATHETER 060039 PF 10PK 6F AL III 100
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0600090·Tray Insert, Level II
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0600090·Tray Insert, Lumbar Instruments, 1
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0600090·Tray Insert, Disc Prep 2
Durable BP Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935104124·
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ATTAIN STARFIX MODEL 4195 LEAD
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·June 12, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 30, 2020
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·ATTAIN STARFIX LEAD
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·ATTAIN STARFIX LEAD DRUG COMBINATION
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain StarFix Lead