10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HANCOCK * OBTURATORS
FDA 510(k)
FDA Class 1
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828018850·ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
ACUMED
FDA UDI
Acumed LLC·10806378052118·7.3mm_6.5mm Screw Holding Sleeve
MEDTRONIC C315 DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
ENDURANT STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·October 23, 2012
MAGIC 3 FEMALE INTERMITTENT CATHETER
FDA Adverse Event
Malfunction
·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025