112 results · 20ms · Sources: EU EUDAMED, US FDA

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Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·NOVACOR LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·NOVACOR N100PCQ LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·WORLD HEART NOVACOR N100PC AND N100PCQ :VAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·NOVACOR LVAS

Pro Advantage

FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P0800123·Pro Advantage Urinalysis Reagent Strips 2 Param...

DeltaForm HD

FDA UDI
Merz Dental GmbH·D7091980012·DeltaForm HighDefinition posterior; shade A2; s...

CREATINE KINASE REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

9800 12

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 7, 2011

OEC 9800 12

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2010

OEC 9800 12 STANDAR

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2010

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·January 24, 2011

PULSE GENERATOR, PERMANENT, IMPLANTABLE

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·June 9, 2016

ADAPTA DR

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·June 10, 2015

ADAPTA D

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·June 10, 2015