8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
COLD LIGHT SOURCE LOS XL-A 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150652·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 200mm
Volpara Imaging Software
FDA 510(k)
FDA Class 2
·Radiology
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
FDA 510(k)
FDA Class 2
·Dental
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 7, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORP·Product code FRN·July 16, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024