10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756364430·CCASC LAPAROTOMY PACK PGYBK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756104210·HAND SPLINT
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
FDA 510(k)
FDA Class 2
·Immunology
CS1000 LIGHT THERAPY DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 11, 2013
LIGHTSHEER (ALL MODELS)
FDA Adverse Event
Injury
·RH USA, INC.·Product code GEX·November 19, 2010
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·July 2, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024