21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROTEX STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502860·LEKSELL STEREOTACTIC SYSTEM CLAMP - HEADREST SU...
PERCLOSE PROGLIDE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MGB·November 20, 2024
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·January 10, 2024
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 28, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 18, 2024
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 1, 2024
KLEENSPEC 590 SERIES DISP VAGINAL SPECULA
FDA Adverse Event
Malfunction
·WELCH ALLYN·Product code HIB·March 13, 2013
EMBOSHIELD EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·April 5, 2011
ALENTI
FDA Adverse Event
Injury
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·May 8, 2008
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 8, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 8, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 8, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 8, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 4, 2024
PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 8, 2018
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 4, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024