17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ArgenZ HT+ 98x18 ML A4B
FDA UDI
ARGEN CORPORATION, THE·D818130354·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013711·RONIS JOINT KNIFE
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
FDA 510(k)
FDA Class 2
·Dental
PRIMAL OK INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO·Product code FPO·March 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·May 9, 2011
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 20, 2023
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015