12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PERCUGUARD
FDA 510(k)
FDA Class 1
·General Hospital
Deka Luxea
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEAMFREE
FDA 510(k)
FDA Class 2
·Dental
ANCHOR C DIAM.3.5MM SELF TAPPING 10MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-SWITZERLAND·Product code OVE·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
TRANSVENE RV
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 8, 2014
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
COD.712 TOP CIRC.RACC.CARDIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTN·December 15, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024