7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
FDA 510(k)
FDA Class 2
·Cardiovascular
Genesys Spine 3DP AIS-C II Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012
SIGMA PS CEM FEM SZ2.5 R
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 7, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024