10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REFLECTION ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROMATE FRAMELESS GEN II
FDA 510(k)
FDA Class 2
·Neurology
MODEL 509M PULSE OXIMETER, MODEL 509M
FDA 510(k)
FDA Class 2
·Cardiovascular
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025
ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 29, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FPO·November 30, 2010
CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE
FDA Adverse Event
Injury
·CIBA VISION·Product code LPN·July 9, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020