1,307 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL SPHERE SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
LPC-PLUS ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·April 23, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 1, 2011
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 26, 2016
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·March 10, 2016
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 5, 2017
COOK CELECT JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
COOK CELECT JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·January 5, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·March 17, 2015
COOK CELECT FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 19, 2015
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 24, 2014
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·June 17, 2016