132 results · 19ms · Sources: EU EUDAMED, 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