7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
SOMAVAC Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 3, 2014
SWEET TIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 10, 2012
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 27, 2007
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024