9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PE/Cyanine7 anti-human CD23
FDA UDI
BIOLEGEND, INC.·00810034701848·URL: https://www.biolegend.com/en-us/products/p...
UNITY BETA ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Portable Mesh Nebulizer
FDA 510(k)
FDA Class 2
·Anesthesiology
SMART PERFUSION PACK: APEX MBR FMC/MID WEST REG LEXINGTON, KY
FDA Adverse Event
Injury
·Product code DTZ·September 11, 2007
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 31, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
S5 MAST ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 10, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024