10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CUP BIOPSY FORCEPS, CURVED DOWN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Legacy™ Implant Closed-Tray Transfer-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307121466·
Legacy™ Implant Closed-Tray Transfer-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307134336·
FORA GTel Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO VALEO VBR
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
TPS MICRO DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·October 14, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 15, 2012
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·October 17, 2018
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015