25 results · 23ms · Sources: EU EUDAMED, 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