9 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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BODY FAT ANALYZER, MODEL HBF-306
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040015254·Zirlux 16+ 0M2 85x40x22
Precision Spine Midline Cortical Surgical Illuminator
FDA UDI
Lumitex, Inc.·00812432021306·
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 19, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 9, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 10, 2008
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