13 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Integrity Spine Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304674424·
C CHANGE SOLUTION WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
FDA 510(k)
FDA Unclassified
·Unknown
BIOMET ORTHOPAEDIC SALVAGE SYSTEM - OSS 0MM SPIKED WASHER BOLT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 28, 2017
BIOMET ORTHOPAEDIC SALVAGE SYSTEM- OSS 2MM SPIKED WASHER BOLT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 28, 2017
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 31, 2022
ATTAIN ABILITY OTW
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
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