10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
EBV EA-D IGG ELISA KIT, MODEL EBG-100
FDA 510(k)
FDA Class 1
·Microbiology
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
KSEA FIBERSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES SCALLOPED DISTAL TIBIA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM MODULAR HEAD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 26, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 25, 2011
ATLAS DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·August 19, 2014
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014