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OMF ASP System

FDA 510(k)
FDA Class 2 ·Dental

OMF-7101 FETAL MONITOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

DARBY PLASTIC HUB NEEDLE 30GA SHORT

FDA Adverse Event
Injury ·SOFIC·Product code DZM·July 17, 2025

DARBY PLASTIC HUB NEEDLE 30GA SHORT

FDA Adverse Event
Injury ·SOFIC·Product code DZM·July 17, 2025

Salmonella O Group Pool OMF serum, 3 mL

FDA UDI
Ssi Diagnostica A/S·05713106402177·Rabbit anitserum, Ready to use

Salmonella O Group Pool OMF serum, 1 mL

FDA UDI
Ssi Diagnostica A/S·05713106735275·Rabbit anitserum, Ready to use

PRESOURCE LACERATION TRAY

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code OJV·September 15, 2025

4085 SURGICAL TABLE

FDA Adverse Event
No answer provided ·STERIS CORPORATION·Product code FQO·March 21, 2022

BYTE NIGHT ALIGNER

FDA Adverse Event
Injury ·STRAIGHT SMILE , LLC·Product code NXC·March 13, 2024

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NPZ·June 17, 2010

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NPZ·May 10, 2016

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 21, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 22, 2013

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·November 13, 2014

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NPZ·February 5, 2010

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NPZ·January 8, 2010

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NPZ·July 14, 2015

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NPZ·July 14, 2015

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NPZ·July 14, 2015