76 results · 28ms · Sources: EU EUDAMED, 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