9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CARDIAC PROBE
FDA 510(k)
FDA Class 1
·Radiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763494345·MIS Cannulated Screw, Ø10.5 x 95mm, Ø6.0mm Rod
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110676·SILICONE SLEEVES PACK OF 6
Sonosite iLOOK Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
FDA 510(k)
FDA Class 2
·General Hospital
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
HENYI ENTERPRISE·Product code FSA·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 19, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 14, 2010
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025