13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RH-950
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033192·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
PALATAL BAR
FDA UDI
Ortho Organizers, Inc.·00190707055806·Beta Titanium Reverse Loop Palatal Bar 37mm
SONICATOR PLUS 930, MODEL ME 930
FDA 510(k)
FDA Class 2
·Physical Medicine
MAGNETIC CONCERTO
FDA 510(k)
FDA Class 2
·Radiology
BD LUER-LOK¿
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 4, 2022
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 3, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 28, 2011
FREER SEPTUM ELEVATOR
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GEG·April 23, 2008
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSD·April 10, 2024
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 28, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024