76 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEMI-TUBULAR PLATE, 19-HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029024·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm
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
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·September 22, 2006
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·October 20, 2006
STERILE SUBDERMAL NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
SINGLE SIZE TENDON SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·May 19, 2006
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code GJS·June 9, 2006
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·April 16, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 4, 2014
LIVIAN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·THE COOL POINT IRRIGATION PUMP