8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER PRESSURE MONITOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CryoVizion System
FDA 510(k)
FDA Unclassified
·Unknown
SAS EDUCATIONAL CHART
FDA 510(k)
FDA Class 1
·Physical Medicine
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
GOBED+
FDA Adverse Event
STRYKER MEDICAL QUEBEC LP·Product code FNL·October 21, 2010
SMALL CLIP APPLIER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 21, 2012
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022