16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
B. FRAGTEX
FDA 510(k)
FDA Class 1
·Microbiology
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
LnK Lumbar Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 18, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 18, 2010
EON PATIENT PROGRAMMER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 2012
BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019
BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019
BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019
VANGUARD (TM) PS OPEN BOX FEMORAL RIGHT INTERLOK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019
VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019
VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019
BIOMET ARCOM ALL POLY PAT. BUTTON
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019
BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020