51 results · 27ms · Sources: EU EUDAMED, 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