112 results
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20ms
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Sources: EU EUDAMED, US FDA
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