11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WallFlex Biliary RX Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
FDA 510(k)
FDA Class 2
·General Hospital
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 29, 2021
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 23, 2019
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
MAXI TWIN
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·June 20, 2011
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code LPH·July 12, 2013
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026