11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GII SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032604·Baltic Denture System BDLoad Mm7 PLSEbim6DFm D3...
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 7, 2025
GENTLECATH INTERMITTENT URINARY CATHETER
FDA Adverse Event
Other
·CONVATEC·Product code KOD·April 1, 2013
ENVISION CT INJECTION SYSTEM
FDA Adverse Event
Injury
·MEDRAD·Product code IZQ·March 23, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code MHY·April 22, 2008
Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·December 15, 2003
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016