8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV
FDA 510(k)
FDA Class 1
·Ophthalmic
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016753·STR, 10 electrode, MPD-CS-L, 2-8-2-8-2-8-2-8-2m...
BLOOD PRESSURE MONITOR/ MODELS
FDA 510(k)
FDA Class 2
·Cardiovascular
ALOKA SSD-4000
FDA 510(k)
FDA Class 2
·Radiology
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 9, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·November 20, 2010
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