8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OTICON, E25P
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VERSAPORT V2 BLADELESS OPTICAL TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOUNIVERSAL PKF
FDA 510(k)
FDA Class 2
·Dental
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 14, 2014
HURRICANE¿ RX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code FGE·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018