27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System
FDA 510(k)
FDA Class 2
·Orthopedic
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
2.0MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036088620·
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PMC LAPAROSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·February 5, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·February 6, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·February 5, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·February 5, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·February 5, 2016
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·December 31, 2019
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·October 26, 2011
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·October 27, 2014
HERCULES 3 STAGE BALLOON ESOPHAGEAL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNQ·July 29, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
EVOLVE(R)
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWI·October 3, 2018
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·January 17, 2017
HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 28, 2014
CHPV
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S. A.·Product code JXG·September 30, 2015
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code OVD·November 16, 2020