25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
FDA 510(k)
FDA Class 2
·Immunology
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837051433·Pilot Rod End
BACKSTOP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASTRONOMER PLUS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 13, 2019
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
OXIMAX
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT, INC·Product code MUD·May 2, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
PINNACLE SECTOR II CUP 48MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 3, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 29, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 4, 2020
NEXGEN PROVISIONAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 31, 2019
VANGUARD MONO FINNED STM TIB 71X14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·December 9, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 7, 2021
VANGUARD ROCC TIB BRG UHMWPE 60X10MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 30, 2021