10 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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ACCELERATOR APS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198192·AK3 PS Insert Trial Size 3, 18mm
LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
FDA 510(k)
FDA Class 2
·Hematology
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·May 6, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·September 16, 2014
HUDSON CONCHA NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·April 15, 2011
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