8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KENDALL URODYNAMIC CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GEODESIC EEG SYSTEM SERIES 100
FDA 510(k)
FDA Class 2
·Neurology
GYNECARE TVT OBTURATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code OTN·November 18, 2019
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 14, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·December 21, 2012
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024