9 results
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33ms
·
Sources: EU EUDAMED, US FDA
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
FDA 510(k)
FDA Class 2
·Immunology
artegral life
FDA UDI
Merz Dental GmbH·D7091993549·anteriors; shade BL1; mould UCS
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA High Performance (HP) Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 7, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 8, 2014
SM PLUS BTT/OVAL BALLOON DISSECTOR
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·January 21, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024