10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
STERILE SILICONE EXTERNAL WOUND COVER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982065·posteriors; shade B4; size XL; lower jaw
Sklar®
FDA UDI
SKLAR CORPORATION·10649111380495·GOMEL MICRO SCISSORS CVD 5.5"
MESH TSL - PELVICOL¿
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·September 21, 2018
EVOLUX CAD/CAM PMMA BLOCKS
FDA 510(k)
FDA Class 2
·Dental
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
FDA 510(k)
FDA Class 2
·Neurology
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·February 8, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 9, 2011
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024