8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Catalys Precision Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
LUNEAU STERILE TONOMETER SEPARATION PRISMS
FDA 510(k)
FDA Class 2
·Ophthalmic
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2021
QUICKSITE LV
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008
RAPID RHINO EPISTAXIS DEVICE
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code EMX·August 18, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026