157 results
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30ms
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Sources: EU EUDAMED, US FDA
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
RHA® 4
FDA UDI
Teoxane SA·07640173230069·One box of RHA® 4 contains two blisters and one...
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOSEAL ENDOSCOPIC APPLICATOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code LMF·July 17, 2008
PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 5, 2019
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 26, 2017
ACTIVA PC+S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 9, 2018
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 29, 2018
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·BRIO NEUROSTIMULATION SYSTEM
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·December 28, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 1, 2013
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 28, 2017
LIBERTA RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code MHY·June 7, 2024
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·April 13, 2018
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 3, 2019
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MBX·February 19, 2019
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 8, 2020
ACTIVA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 9, 2013