10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SELF SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294286·
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX FIXATION PINS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 22, 2013
EXPRESS 4
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code JQC·August 12, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 28, 2011
NIBP CUFFS
FDA Adverse Event
Injury
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012