8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SK S-RAY GRIDS
FDA 510(k)
FDA Class 1
·Radiology
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
FDA 510(k)
FDA Class 2
·Anesthesiology
CRITIKON VITAL SIGNS MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
OPERATING CYSTOSCOPE-URETHROSCOPE
FDA Adverse Event
Death
·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 4, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024