13 results · 35ms · Sources: EU EUDAMED, 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