14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XIDF-100A/B1 IMAGE PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
FDA 510(k)
FDA Class 2
·General Hospital
SINGLE USE INJECTOR
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FCG·June 6, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 21, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·Product code MGB·January 28, 2011
DURAL ALPHA INSERT W RIM II/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·March 12, 2019
DURASUL, ALPHA INSERT, HOODED, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·September 28, 2018
METASUL, ALPHA INSERT, JJ/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 4, 2019
DURASUL, ALPHA INSERT, KK/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
COCR HEAD 32/ 0 'M' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·June 4, 2019
DURASUL, ALPHA INSERT, LL/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 29, 2019
DURASUL, ALPHA INSERT, HOODED, KK/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·June 15, 2018
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024