9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLOOD PRESSURE METER, MODEL CH-4532
FDA 510(k)
FDA Class 2
·Cardiovascular
VIVID 7 WITH SONOPAC, MODEL FB0008XX
FDA 510(k)
FDA Class 2
·Radiology
OMNI OXYGEN SYSTEM, MODEL 1000
FDA 510(k)
FDA Class 2
·Anesthesiology
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·April 25, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 16, 2014
LIGHTSPEED VCT
FDA Adverse Event
Other
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 29, 2015
NEONATAL PATIENT CIRCUIT KIT
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 21, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024