14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTIS pheno (VE21) System
FDA 510(k)
FDA Class 2
·Radiology
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220409150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220409000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220409070·
PICCOLO COMPOSITE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STEAMPLUS STERILIZATION TEST
FDA 510(k)
FDA Class 2
·General Hospital
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·August 23, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 4, 2008
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
EasyPoint Needle, 25G x 5/8", REF: 82091
FDA Enforcement
Class II
·Ongoing·Retractable Technologies, Inc.·March 20, 2024
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020