12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Monster BITE Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOOP RECORDER VITAPHONE, 3100 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDFOOT FUSION PLATE SMALL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·October 8, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·June 8, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 14, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 19, 2020
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023