19 results
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22ms
·
Sources: EU EUDAMED, US FDA
VENTRESIGN STREP A TEST
FDA 510(k)
FDA Class 1
·Microbiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756738231·MASTOID PACK
GRIESHABER VISCOELASTIC INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
GX-2000 STATIONARY X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·January 31, 2024
LIGACLIP CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·June 26, 2014
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·January 4, 2013
TRIGEN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HWC·November 11, 2010
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·July 10, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 10, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 23, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 2, 2023
MASTOID PACK
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code KDD·June 1, 2015
SYMPHYSPL 3.5 W/COAX-COMBIHO+2 DCP 6HO L
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HRS·December 13, 2017
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021