8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MACHIDA NASOPHARYNGO-LARYNGOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AGILLS PF DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·September 25, 2020
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·November 5, 2007
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024