35 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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087 Balloon Guide Catheter System
FDA 510(k)
FDA Class 2
·Cardiovascular
FREQUENCER MODEL V2X
FDA 510(k)
FDA Class 2
·Anesthesiology
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
FDA 510(k)
FDA Class 2
·Dental
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 4, 2023
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 7, 2008
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 26, 2011
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·April 18, 2024
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 11, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 7, 2024
VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 1, 2024
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·March 20, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 17, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·June 8, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·June 3, 2024
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·February 28, 2023
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·February 15, 2023