16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020386·INTRG WHISP-Z ROTH 1BICHK -17T 0A 022 LL
LIQUID ASSAYED MULTIQUAL PREMIUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LAWRENCE CSERION, MODEL CS-1
FDA 510(k)
FDA Class 2
·Radiology
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024
BATTERY 14.8V, 6.3 AH LI-LON BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 24, 2014
SYNCHRON® CX9 ALX CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 1, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 16, 2013
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025
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
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015