14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DigiLine Direct Print Aligner System
FDA 510(k)
FDA Class 2
·Dental
PISCES-SA Standalone ALIF Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
FDA 510(k)
FDA Class 2
·Microbiology
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
PUMP MMT-722LNAP PRDGM INS PL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·November 14, 2008
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
ZOOM STRETCHER, PRIME X
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·July 18, 2013
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025