10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aquilion Serve (TSX-307A/1) V1.3
FDA 510(k)
FDA Class 2
·Radiology
ERGO SRS
FDA 510(k)
FDA Class 2
·Radiology
PASS LP Spinal System, CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 31, 2025
PEGASUS GN 18GA X 1.16IN PRN-CAP Y
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 24, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code GJS·July 25, 2011
MEDTRONIC
FDA Adverse Event
Other
·MEDTRONIC, INC·Product code FPA·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
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