12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGILON® XO Shoulder Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902316572·BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg
FLOWER SMALL AND MEDIUM IMPLANT SET
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER SPINE OASYS BONE SCREW
FDA 510(k)
FDA Unclassified
·Unknown
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 12, 2014
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 14, 2008
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 1, 2011
ALIGN RS URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·July 12, 2013
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 18, 2018