10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PRESERVE LUBRICANT CODE NO. 43=4035
FDA 510(k)
FDA Class 1
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515199224·Bone File, doubled sided, 8"
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776339104·Bone File, #12A, double ended,
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HYPER SAL
FDA 510(k)
FDA Class 2
·Anesthesiology
HEALIX ADVANCE BR 4.5 MM, 3 SUTURE W/ORTHOCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·July 26, 2018
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2007
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014
CRESCENT SPINAL SYSTEM
FDA Adverse Event
MSD DEGGENDORF MFG·Product code MAX·October 3, 2012
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