16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANS1 FACET SCREWS
FDA 510(k)
FDA Unclassified
·Unknown
ABL80 FLEX CO-OX with AQURE connectivity
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROSTHESIS, INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·January 13, 2017
PROSTHESIS, INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·January 13, 2017
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 5, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·January 20, 2012
UNK - PLATES: 2.0 MM LOCK MANDIBLE MINIPLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 16, 2021
UNK - PLATES: 2.0 MM LOCK MANDIBLE MINIPLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·September 16, 2021
UNK - SCREWS: LOCKING: MANDIBLE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·September 16, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·March 22, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·March 22, 2018
PROSTHESIS, INTERVERTEBRAL DISC
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MJO·January 13, 2017
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017