11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Monet Curing Laser
FDA 510(k)
FDA Class 2
·Dental
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·January 15, 2024
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
AXIUM 3D AND HELIX DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·April 8, 2008
ONE TOUCH SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 12, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 1, 2011
PLV-102
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·July 15, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014