21 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nexy
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239618·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304479487·
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
SOUND SURGICAL VASER 2.1 LIPO SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
URETERO-RENO VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FGB·December 30, 2025
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·February 2, 2026
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·November 5, 2025
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 27, 2011
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 17, 2014
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020