22 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEONE SPA
FDA UDI
LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown
ConMed
FDA UDI
Provision·B504OM50911020·
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217641·
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180507209·Cup Curette, Up-Angled, Medium
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
FDA 510(k)
FDA Class 2
·General Hospital
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 10, 2025
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
BIPOLAR INSERT CEV633-1A 350MM BOTELLA
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013
PASSPORT V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
DEXTRUS 4136
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·May 3, 2011
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·March 28, 2013
TUBE CEV649-5B DIA 5MM 350MM
FDA Adverse Event
Malfunction
·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 23, 2026
HANDLE CEV10395R DIA 5MM ANG W/O RATCHET
FDA Adverse Event
Malfunction
·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 23, 2026
INSERT CEV625-1 FENESTRATED 350MM
FDA Adverse Event
Malfunction
·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 30, 2026