7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPECTRON CONVERSION ENDOPROSTHESIS CUP
FDA 510(k)
FDA Class 2
·Orthopedic
TENS PRO 900
FDA 510(k)
FDA Class 2
·Neurology
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 2, 2014
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 8, 2015
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024