26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDIUS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033562796·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140000·Counter Torque, Offset Handle Assembly
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0140100·Set Screw Driver Shaft, Final Torque, T15
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140000·Counter Torque, Standard and Extended Tab
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140200·T-Handle, T30 Split Tip Cap Starter
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GOOD SAM CINCINNATI OH 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008
ORTHOPEDIC SALVAGE SYSTEM (OSS) TIBIAL BEARING 20MM STANDARD ARCOM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·December 2, 2016
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·March 14, 2008
ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE - DEVIATIONS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·December 2, 2016
ORTHOPEDIC SALVAGE SYSTEM (OSS) BUMPER LOCKING PIN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·December 2, 2016
ORTHOPEDIC SALVAGE SYSTEM (OSS) RS AXLE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·December 2, 2016
ORTHOPEDIC SALVAGE SYSTEM (OSS) RS FEMORAL BUSHINGS SET ARCOM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·December 2, 2016
50MM LEFT MAND COMPONENT TI
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·July 11, 2022
ORTHOPEDIC SALVAGE SYSTEM (OSS) BUMPER LOCKING PIN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KRO·December 2, 2016