16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELEBRITY XL SC445
FDA 510(k)
FDA Class 2
·Physical Medicine
FLEXIBLE AND RIGID URETEROTOME SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OTOSONIC ACS-ASP
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·January 31, 2024
SUPERIOR END PLATE MEDIUM 6°-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·February 6, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·July 18, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011
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·June 2, 2023
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
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
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017