51 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635891·CoRoent Ant TLIF PEEK, 11x10x28mm 15°
AOS TIBIAL NAIL 10mm x 28.5cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016109·
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584634·Apex Tibial Nail Ø 11.0 x 285mm
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
LITETOUCH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTOUR PROFILE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 15, 2002
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·February 7, 2022
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·October 12, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·November 17, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·December 1, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 22, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·June 13, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 27, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·January 5, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·February 5, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·January 26, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·February 1, 2023