12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DELFIA PLATE FLUOROMETER 1232
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PALS
FDA UDI
AXELGAARD MANUFACTURING CO., LTD.·00856817005475·
TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·December 21, 2020
TRANS/V NEEDLE GUIDE
FDA 510(k)
FDA Class 2
·Radiology
BEHIND THE EAR HEARING AIDS MODEL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·December 13, 2020
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·June 25, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·November 8, 2010
MITEK HEALIX PEEK ANCHOR, 6.5MM W/ORTHOCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·January 3, 2013
TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 4, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020