8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVOSIGHT TOPICAL OCT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198369·AK3 PS Insert Trial Size 5, 20mm
NEXAN SYSTEM, MODEL NX-300
FDA 510(k)
FDA Class 2
·Cardiovascular
BLUEPHASE
FDA 510(k)
FDA Class 2
·Dental
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 6, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
PROTIME MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·April 6, 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