9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VISION TESTER
FDA 510(k)
FDA Class 1
·Ophthalmic
Buxton BioMedical
FDA UDI
Buxton Biomedical Inc·B7688430420·Sm-Hndl Punch, 180x4mm,40°up
SonarMed AirWave, Airway Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Zimmer, Inc.·00889024195509·
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·June 2, 2014
OT VERIO PRO METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·September 23, 2010
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