9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SPACE-OR RETRACTOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993544·anteriors; shade BL1; mould ITL
HANDI PORCH ELEVATOR & LIBERTY WHEELCHAIR LIFT
FDA 510(k)
FDA Class 2
·Physical Medicine
TROPAZONE CR
FDA 510(k)
FDA Unclassified
·Unknown
PS TIBIAL INSERTS SZ 1, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 15, 2023
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 7, 2013
ETS*45 ENDO LIN CUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 16, 2011
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024