8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HumaPen Savvio
FDA 510(k)
FDA Class 2
·General Hospital
SAFE TIP SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
NEMA-ST, MODEL V1.0.2
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·Product code OYC·June 10, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
PROXIMATE RELOADABLE LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 5, 2008
HAMILTON-C6
FDA Adverse Event
Death
·HAMILTON MEDICAL AG·Product code CBK·December 7, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024